QC Equipment Specialist

  • Location: Braine-l'Alleud
  • Job #25387

QC Equipment Specialist
Join the QC team, working with a substantial analytical equipment park. The role goes beyond just qualification and maintenance of equipment, focusing primarily on the coordination of various activities related to these pieces of equipment. This role is akin to that of an architect, as it requires an overall view of the equipment's lifecycle.

The Responsibilities

  • Equipment Management:
    • In the event of a breakdown, identify and coordinate necessary actions with internal and external stakeholders.
    • Follow-up on equipment, install new equipment, and manage related projects.
    • Coordinate with support departments to ensure proper maintenance, qualification, and installation of equipment.
    • Project Management: Track timelines, budgets, and required resources for installation or upgrades of equipment.

 

  • Activity Coordination:
    • Serve as the point of contact for different stakeholders: qualification/validation, maintenance, IT, QA, laboratory (end users).
    • Perform testing, when necessary, in collaboration with the laboratory.
    • Ensure smooth execution of projects while adjusting priorities and juggling multiple tasks.

 

  • Planning and Monitoring
    • Manage several simultaneous projects, with up to 4 to 5 pieces of equipment to manage per person.
    • Use the Integrate software to track various projects and activities.

Required Skills and Profile

    • Rigorous and Organized: The candidate must be highly structured and able to manage shifting priorities.
    • Multitasking: Ability to work on multiple projects at once, sometimes dealing with urgent changes in priorities.
    • Experience with Laboratory Equipment: Knowledge of analytical equipment in GMP (Good Manufacturing Practices), such as HPLC, UPLC, UV, Infrared, PCR vessels, fridges, and freezers.
    • Familiarity with LIMS, Source, and Integrate systems is a plus.
    • Communication Skills: Ability to understand and write documentation in English (B2 level minimum), as equipment documentation is mostly in English. Ability to communicate with external suppliers and manage international interactions.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]

Research Scientist Regulatory Bioanalysis

  • Location: Braine-l'Alleud
  • Job #25357

Research Scientist Regulatory Bioanalysis
Le consultant devra assurer la réalisation dans les meilleures conditions de qualité et de délai, le développement et la validation de processus bio-analytiques automatisés en environnement régulé GLP & GCP (BPL & BPC). Ces processus devront suivre et respecter les règles des Bonnes Pratiques de Laboratoire et les sections applicables des Bonnes Pratiques Cliniques.
Ces processus auront pour but la quantification des analytes présents dans les échantillons biologiques provenant d’études précliniques et cliniques.
La fonction s’appliquera aux points suivants :
À la sélection, à l’implémentation et à la validation (computerized system validation for GLP and GCP activities) d’applications et d’instruments utiles au laboratoire de bioanalyses.
Au développement de méthodes et de processus automatisés, utiles à la gestion et à la manipulation d’échantillons tests provenant de divers laboratoires, services ou départements, ou sous-traitants (études de pharmacocinétique, toxicologie, pharmacologie).

Les Responsabilités

  • Assurer de la bonne gestion du matériel et des équipements de laboratoire (maintenance, calibration, qualification), en tant qu’utilisateur, responsable d’appareil ou suppléant.
  • Développer des méthodes et des processus bio-analytiques automatisées.
  • Être responsable de la validation des applications et des instruments du laboratoire.
  • Réaliser les essais au laboratoire, et parfaire sa formation technique et scientifique.
  • Prévoir les besoins en produits, réactifs et matériel de laboratoire nécessaires à la réalisation des objectifs qui lui sont confiés.
  • Rédiger et revoir des procédures d’opération standards.
  • Assurer la conformité aux normes GLP & GCP.
  • Veiller au respect des procédures de travail et de sécurité.
  • Suivre l’évolution des connaissances dans les domaines techniques et scientifiques qui relèvent de la spécialisation du laboratoire et des objectifs qui lui sont confiés.

Connaissances et Expériences requises

  • Une connaissance pratique des normes GLP & GCP.
  • Développement de méthodes et de processus.
  • Rédaction et revue des procédures.

Notre Offre
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

Analytical Scientist

  • Location: Braine-l'Alleud
  • Job #25352

Analytical Scientist
To strengthen our Analytical Sciences for our client, we are looking for an Analytical Scientist with a strong experience in analytical development, process support and at least hyphenated analytical techniques (Nuclear Magnetic Resonance – NMR). The position is based in our Characterization and Material Sciences department on their site in Braine l’Alleud, Belgium.
In this role, you will contribute to the end-to-end analytical development of our small molecule and peptide portfolio, from preclinical through to the launch and the lifecycle of our marketed products.

The Responsibilities

  • Ensuring day to day NMR analysis.
  • Ensuring release and stability testing of API, standards, and clinical batches from Phase I to Phase III.
  • Ensuring release testing of raw materials, starting materials, degradation products and intermediate of synthesis.
  • Developing and validating fit-for-purpose of analytical methods according to aQbD principles (risk assessment, DoE, modelling) for APIs, Drug Products and In Process Control (IPC).
  • Transferring analytical methods to CDMOs, QC and manufacturing units and participating in their lifecycle management.
  • Providing high quality documentation of all technical work performed in the laboratory.
  • Actively participating to project meetings as well as internal scientific meetings.
  • Participating to the implementation of new state-of-the-art analytical methodologies and process improvements including bibliographic survey, technical scouting, and innovative methodological evaluation

Education Experience and Skills Required

  • This position requires a bachelor/master’s degree with at least 2 years’ experience (e.g. Analytical Chemistry) in the pharmaceutical industry is required.
  • Competence and autonomy in analytical development with NMR spectrometers.
  • Basic knowledge of NMR is highly recommended.
  • Key areas of expertise are the following:
  • Experience in NMR for characterization, quantification, and structural identification of compounds.
  • Experience in the development of analytical methods for small molecules and/or peptides.
  • Understanding of regulatory, GMP and safety environments
  • Experience using Bruker instruments and knowledge of Topspin/MestReNova is a plus.
  • Knowledge of organic chemistry to facilitate the interpretation of spectroscopy results is a plus.
  • Knowledge of the other characterization techniques (MS / IR / NIR / …)
  • Key skills are the following:
  • Able to work and respect the procedures in a regulated environment including good practices and HSE.
  • Good interpersonal, verbal, and written communication skills in French and/or English.
  • Team player, highly motivated with a strong client orientation.
  • Demonstrated motivation for laboratory work and hands-on experience with analytical instruments.
  • Ability to work in a matrix organization in different technical areas.
  • Be able to find autonomously technical solutions and activate all appropriate internal /external experts to solve the issue.
  • Be able to efficiently translate the data collected into knowledge that meets the needs of the project.
  • Must be able to manage scientific tasks independently to meet deadlines within given challenging timelines. 

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
 

Industrial Lead Analytical (ILA) Specialist

  • Location: Braine-l'Alleud
  • Job #25276

Industrial Lead Analytical (ILA) Specialist

The scope of the position is global within the entire Transformational Programs & Infrastructure Department of our client’s company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead (ILA) of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products.

The Responsibilities

  • Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …).
  • Implementing analytical life cycle plans or integrated analytical solutions through project management.
  • Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department.
  • Supporting ILAs for operational activities within the remit of the department.
  • Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO).
  • Use your project management skills to implement decisions, plans, and solutions.
  • Show-off your energy and dynamism to evolve in a complex matrix environment.
  • Work in autonomy with a problem solving & pragmatic mindset.
  • Work on several projects in parallel with agility and smooth communication to support members of the team.

Skills and Knowledge Requirements

  • Master’s degree in analytical chemistry or biology
  • Industrial experience in the analytical testing field of pharmaceutical products with some project management activities.
  • Experience of contact with QCs Experience in Biological products is a plus.
  • Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting to team manager.
  • Knowledge of QC laboratory work, LIMS knowledge is a plus.
  • Support of operational activities such as sample shipment, request of QC data, support QC trouble shooting, support to deviations.
  • Exposure to GMP, Regulatory Affairs and Quality applied to analytical.
  • Fluent in English and French.
  • Customer and results oriented.
  • Ability to summarize challenges and issues to management.
  • Knowledge of basic Microsoft tools (Teams, Excel, Powerpoint, …).
  • Ability to review data and documentation with a scientific eye.
  • Knowledge of pharmacopeias and Biological and Physchem methods is a plus.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
 

Vendor Quality Lead Drug Product

  • Location: braine l'alleud
  • Job #25267

Vendor Quality Lead Drug Product
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for our client’s Products.

The Responsibilities

  • Be the central QA point of contact for the organization for investigations / deviations / out of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, ILA, ALO, Business) to allow assessment.
  • Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, Side impact) and track the vendor’s performance.
  • Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
  • Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
  • If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) escalation meeting. Coordinate vendor quality related investigations.
  • Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
  • Work closely with Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.

The Skills and Knowledge Requirements

  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
  • Must be able to act in most circumstances without direct supervision and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
  • Possess good auditing capabilities and skills.
  • Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
  • Root cause and risk management/assessment skills

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Please reach out to Aylin, [email protected]

SAP System Quality Support

  • Location: braine l'alleud
  • Job #25248

SAP System Quality Support

This global position as SAP System Quality Support will provide secondment to the main SAP System Quality Partner to deliver major projects linked to SAP PE1, more specifically linked to the Quality and Batch Management Modules. The goal will be to link business needs and IT constraints, to deliver lean processes within the modules and ensure sustainability through E2E testing. The function will provide QA expertise supporting continuous improvement such as reworking, standardization and alignment of processes; but also writing of procedures, trainings and coaching of local key users.

The Responsibilities
The SAP System Quality Support for Quality and Batch Management function in alignment with and under the guidance of the main SAP System Quality Partner will:

  • Link business needs and IT constraints in projects, to deliver lean processes within the modules.
  • Provide expertise in the modules to improve as much as possible including revamping, standardization, and alignment of processes; writing of procedures, trainings and coaching of local key users who will train End Users.
  • Support incidents investigation, correction, and related improvements to be done in the systems as part of Day-to-day routine activities with IT and business entities.
  • Ensure requested development to IT are matching business requirements by testing in depth new functionalities in systems.
  • Ensure to keep the tool sustainable in order to be also able to support deployment of system upgrades.
  • Help developing a community around the SAP System Quality team, which can be split into two parts: Community across Key users linked to SAP Improvement Project but also community within the module’s QM and BM with related LKUs (local key users).

Skills and Knowledge Requirements

  • Master’s degree required.
  • Strong Knowledge of SAP system preferably in Quality Management; HPALM knowledge is an asset.
  • Must be able to communicate (write/speak) fluently in English (communication with IT outsourced), French is an asset.
  • Analytical mind-set with a capacity to see the bigger picture.
  • Negotiation skills.
  • Strong written and oral communication skills.
  • Self-driven, results-oriented with a positive outlook and a clear focus on high quality
  • Fast learner.
  • The candidate will need to be able to strongly defend Quality and standardization of the processes within the modules by negotiating, analyzing the details while seeing the bigger picture and by ensuring business and IT satisfaction.

Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Aylin Ugurlu at [email protected]

 

SME qualification validation

  • Location: Braine-l'Alleud
  • Job #25229

SME Qualification / Validation

Notre client est à la recherche d’un nouveau SME (Subject Matter Expert) Qualification / Validation dans le cadre de la mise en production de nouveaux systèmes, procédés et équipements GMP informatisés ou non informatisés. La personne aura pour objectif de définir et proposer la stratégie de qualification / validation pour les systèmes, procédés et équipements. Cela comprend :

  • Réalisation/Animation des analyses de risques qualité.
  • Définition de la stratégie de qualification / validation en accord avec l’équipe projet.
  • Rédaction du plan de validation et des documents de qualification associés.
  • Mettre en place une approche efficace et standardisée de qualification et de validation des systèmes, procédés et équipements.

Rôle et Responsabilités

  • Développer un partenariat avec les clients internes, les services support internes (IT, Métrologie, Contrôle périodique) et les fournisseurs externes. 
  • Prendre en charge les projets de qualification / validation des systèmes, procédés et équipements qui lui sont confiés dans le respect des planning définis :
  • Coordination et suivi des activités de qualification / validation confiées
  • Elaboration de la stratégie de qualification / vérification / validation
  • Rédaction des documents de qualification / validation
  • Coordination / exécution des tests
  • Attribution du statut qualifié aux équipements
  • Attribution du statut validé aux procédés
  • Réaliser les Periodic Reviews des systèmes et équipements qui lui qui lui sont confiées :
  • Coordination des « Periodic Review » sous sa responsabilité
  • Etre garant du respect du planning de « Periodic Review » (Requis Compliance)
  • Ré-évaluation du statut qualifié des systèmes et équipements
  • Rédaction des rapports GMP et QUALITE :  Travailler en collaboration avec le Service « Quality Assurance » pour assurer la conformité vis-à-vis des réglementations en vigueur, guidelines, normes et procédures internes (SOP).
  • Participer aux audits internes, audits externes et Inspections réglementaires (autorités nationales, internationales, FDA, EMEA, etc…).  
  • Reporter à sa hiérarchie tout problème ayant un impact sur la qualité des systèmes, des instruments ou des produits fabriqués et/ou en développement.

Qualifications et compétences requises.

  • Bachelier ou master dans un domaine relevant au poste.
  • Minimum 3 à 5 d’expérience dans le scope d’activités.
  • Une expérience solide en qualification et validation d’équipements.
  • Une expérience dans le secteur pharmaceutique.
  • Avoir déjà mené à bien un projet en rapport avec la qualification/validation.

Notre Offre
A la recherche d’un nouveau défi professionnel ? Jefferson Wells vous offre un accompagnement, étape par étape, pour l’accomplissement de votre prochain objectif professionnel. Un contrat en CDI ou une collaboration avec Freelance possible. Une question ? Un doute ? Ou tout simplement intéressé-e par le poste ? Contactez Aylin Ugurlu : [email protected] .

Dev Quality Lab Ops Partner

  • Location: Braine-l'Alleud
  • Job #25228

Dev Quality Lab Ops Partner
Contracting – Walloon Brabant

Your responsibilities ?
Part of the Clinical Manufacturing Quality team, the candidate will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development for:

  • The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing
  • The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE).

The Candidate will also :

  • Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
  • Provide support for qualification and validation activities of the different laboratories and production pilots.
  • Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections).
  • Identify, mitigate and subsequently resolve compliance and quality issues that may affect company development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
  • Ensure adequate QA support for the qualification, validation and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories, as well as related cleaning validations.
  • Train company personnel regarding cGMP/GSP and QMS requirements related to manufacturing and analytical operations for clinical trials and stability studies.
  • Manage Quality Assurance Agreement for New and On-going Supplier.
  • Adjust the Level of Quality and associated procedures based on changing regulatory requirements, technical and scientific knowledge.
  • Implement and maintain a quality risk management process for the systems used in Development.
  • Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of company development activities and ensure compliance with regulatory and corporate requirements.
  • Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
  • Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
  • Manage Quality meetings to maintain adequate level of compliance of the business activities.
  • Ensure and maintain the adequate accreditation for all laboratories (in /out Braine).
  • Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
  • Ensure Development Quality Management System directly support Technical Operations and development partner goals and objectives.
  • Coordinate the local development process for supplier qualification, maintain the training material associated to it, act as facilitator in order to ease the supplier qualification exercises for development activities, act as enabler and support business partners in order to ease the process, ensure operational qualification of development suppliers. Ensure all information available in the different database are up to date, manage the Change notification from suppliers and coordinate assessments with impacted stakeholders, maintain documentation up to date.
  • Coordinate and execute the development management review, ensuring principles mentioned in the associated corporate procedure are fulfilled for development entities.
  • Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to internal audit within development entities, coordinate and update the development internal audit schedule, ensuring appropriate application of the audit planning and also manage Self inspections in the Lab.
  • Act as Vendor Quality Lead back up for on Quality Oversight.

Your profile ?

  • Project Management Skills (tools like MS Project).
  • Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packaging and medical devices).
  • Strong Communication Skills, including experience leading meetings and coordinating between teams.
  • Experience in IT and Automation (networking, IT security, data integrity).
  • Autonomy, the ability to manage multiple projects simultaneously under pressure.
  • Proficiency in French (essential for communication with production) and English (professional level required for international communication).

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]
 

Pharma Process Engineer

  • Location: Braine-l'Alleud
  • Job #25223

Pharma Process Engineer
Contracting – Walloon Brabant

Your responsibilities ?

  • Project Management: Coordinate a portfolio of projects (mainly in secondary packaging and medical devices), ensuring proper management of schedules and critical milestones.
  • Inter-project Coordination: Link technical teams, production, and experts (IT, automation) across different departments.
  • SME Support: Provide technical expertise as needed in engineering and processes, especially in IT, data security, and automation.
  • IT/Automation Project Oversight: Manage projects related to Data Integrity, IT security, and the automation of manufacturing facilities.

Your profile ?

  • Project Management Skills (tools like MS Project).
  • Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packaging and medical devices).
  • Strong Communication Skills, including experience leading meetings and coordinating between teams.
  • Experience in IT and Automation (networking, IT security, data integrity).
  • Autonomy, the ability to manage multiple projects simultaneously under pressure.
  • Proficiency in French (essential for communication with production) and English (professional level required for international communication).

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]

 

Global Quality Auditing Outsourcing R&D Lead

  • Location: Braine-l'Alleud
  • Job #25193

Global Quality Auditing Outsourcing R&D Lead

‘Global Quality Auditing Outsourcing R&D Lead’ implements a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP/GLP Quality Systems. The incumbent is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.

The Responsibilities

  • 1. External Auditing vendor management
  • Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
  • Play a key role to assist in defining, evaluating, and monitoring key performance indicators (KPis) and drive key quality indicators (KQis) for R&D auditing vendors, and assisting with continuous improvement initiatives relating to management of vendors.
  • Review and/or approve required Auditing Documents related to the activities in scope.
  • Prepare, support and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, as per established process, contracts, and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with internal audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf of the company.
  • As required, provide management with a summary and analysis of quality risks and outcomes related to Auditing vendors activities.
  • 2. External Auditing:
  • Contribute and/or participate in the development of the risk based GLP/GCP audit program through evaluation of elements of the internal quality system and their effect on the overall state of compliance of the system.
  • Perform GCP and/or GLP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy).
  • Perform GCP and/or GLP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
  • Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
  • Support the preparation, hosting and follow up of critical Regulatory Authority inspections related to clinical activities, in collaboration with the R&D and PV Quality team.
  • 3. Drive Insights for UCB through Data:
  • Ensure timely and accurate input of audit data in Audit Management Tool.
  • Contribute data and feedback to GCP/GLP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
  • 4. Compliance Issues:
  • Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP/GLP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
  • Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.
  • 5. Consulting, Educating, Quality Improvement, and External Focus:
  • Utilize in-depth knowledge and understanding of current business trends, applicable regulations, and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH/GCP, GLP regulations, other applicable regulatory requirements, and the company global quality standards.
  • Participate in medium-long term projects within competence.
  • Upon the request of/with the approval of Global Quality Auditing Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).

The Skills and Knowledge Requirements

  • Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP/GLP related areas.
  • 3 years’ experience in leading full range of GCP audits for internal processes/units and external partners or vendors, with depth of understanding of the theory and practice of quality management.
  • Experience in the pharmaceutical/biotechnology area including time working in GLP and/or GCLP-related areas.
  • Minimum of 3 years of auditing and 5 years overall dealing with research and development area. Experience in vendor management is a plus.
  • In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
  • knowledge and understanding of Human Tissue Act and the Human Tissue Authority (HTA) codes of practice, GLP, GCLP, Good Research Practices and their applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
  • Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
  • Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
  • High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
  • Fluent in written and spoken English. Additional language skills would be an advantage.
  • Able to travel nationally and internationally as business necessitates,20% of time on average.
  • Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
  • Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with externals and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
  • Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. If you are interested, you can send your CV to [email protected] .