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, CAS, 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, QuickScore) 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.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
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) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging.
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a coach for VQL’s with less experience.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
Master's Degree in Sciences
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 able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
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 or send me your CV, [email protected]
Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
Contribute to release and stability testing in relation to the project, as appropriate.
Prepare, review, and approve documentation (procedures, protocols, reports).
Analyze experimental results.
Verify data accuracy.
Present and discuss results in project team meetings.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.
Your Profile
Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
Proven expertise, preferably in the biotech industry.
Strong, proven laboratory skills.
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
Practical experience and expertise in at least one of the following analytical techniques:
Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
Expertise in analytical method development and validation.
Ability to work autonomously in day-to-day tasks.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules is a plus.
Good English skills (both written and oral) are recommended for reports and communication.
Ability to manage multiple priorities and prioritize effectively.
Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
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 or send me your CV, [email protected]
Primary packaging systems innovation and new products development management :
New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
Clinical medical devices design and assessment
Primary packaging systems life cycle & sustaining management :
Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
Competitors pharmaceuticals primary packaging systems benchmarking management :
Competitors primary packaging systems portfolio analyze & characterization.
Primary packaging materials, components and technology scouting and assessment according to defined priorities
Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Your profile:
Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
Proven track record in project management / Project Management certification will be a distinct advantage
Fluency in French & English
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 or send me your CV, [email protected]
Your responsibilities: Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:
Ensuring that Quality systems are in place/in use, routinely monitored and assessed
Mastering quality agreement content
Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
Identifying risks associated to the specific activities of the CMO
Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities
Your profile:
University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
Fluent in English and French
Excellent communication (including presentation) and influencing skills.
Stakeholders’ management: ability to interact with internal & external stakeholders
Ability to travel to CMO (less than 1x/2month)
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 or send me your CV, [email protected]
Package owner : Supplier management, equipment final design, execution and qualification, P&ID tracking, electrical schematics, project execution (planning, coordination,….).
Your profile:
Master’s degree
Minimum 5 years of experience within pharmaceutical companies and working with Engineering offices
Requires project management experience in pharma, knowledge of qualification, and equipment design.
Experience: Preferably in CAPEX projects within a commercial GMP facility.
Good Upstream and Downstream Process Technical expertise.
Good knowledge in automated system.
Good Knowledge of cGxP requirments.
Automation: Siemens PCS7 knowledge beneficial; the role involves verifying compliance with software requirements.
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 or send me your CV, [email protected]
Location:Brabant Wallon, Région wallonne, Belgique
Job#25834
Qualification-Validation CSV Engineer
Contracting – Brabant Wallon
Vos responsabilités :
Définir et assurer le suivi des stratégies de qualification/validation CSV dans le respect des Bonnes Pratiques de Fabrication et des règles d'hygiène et de Sécurité et conformément au Validation Master Plan du projet.
Evaluer l’impact qualification inhérent aux risques identifiés.
Rédiger les documents de qualification conformément aux SOP de qualification / validation.
Identifier l’approche d’implémentation de ces stratégies (Change Control, autres) dans le cadre du projet.
Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet.
Exécuter et/ou vérifier les tests de qualification / validation des installations en impliquant les futurs utilisateurs et conformément aux procédures en vigueur.
Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation
Donner le support CSV aux activités de l’équipe (gestion de déviations, CAPA, préparation et/ou participation aux audits, …).
Mettre à profit son expertise CSV afin de répondre à des sujets spécifiques (position papers, analyses de risque, …)
Garantir l’auditabilité permanente des dossiers de validation et de qualification des installations
Votre profil :
Bachelor / Master de préférence à orientation informatique/automation industrielle et autrement, dans un domaine scientifique.
Plus de 5 ans d’expérience dans le domaine de la validation dont au moins 3 ans sur les systèmes automatisés et/ou informatisés et en particulier sur des mises à jour / upgrade / revamping de software / firmware.
Compréhension des flux, des pratiques, des méthodologies et des délivrables de validation.
Connaissance confirmée de la partie automation des procédés industriels pharmaceutiques (laveuses, bioréacteurs, autoclave, testeurs de filtres, stations CIP/SIP, biowastes, …).
Connaissances des paramètres et éléments de conception pouvant avoir un impact qualité sur les procédés susmentionnés.
Connaissance des techniques en IT/Computer System Validation.
Bonne connaissance de PCS7
Compréhension et facilité d’expression en anglais.
Capacité à prendre des responsabilités et des décisions.
Rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier.
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Review of product marketing materials to ensure conformity with product claims.
Monitor and communicate regulatory requirements to ensure preparedness for upcoming submissions.
Provide regular updates on the project's progress to internal stakeholders.
Your profile?
Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
Previous experience in Regulatory Affairs (minimum of 1 year on drafting of regulatory documents)
Experience liaising with Health Authorities
In-depth knowledge of the regulatory environment and guidelines.
Experience with generic medicines is an asset.
Good planning and organizational skills
Strong interpersonal communication skills (verbal and written).
English and French required.
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.
Pour notre client spécialisé dans les mécanismes de contrôle d'accès, nous sommes actuellement à la recherche d'un Project Manager. Notre client assure la conception, le prototypage et la vente de ses solutions, tandis que la production des pièces est sous-traitée.
Le Project Manager Engineering travaillera en étroite collaboration avec les Sales Managers (Bid), qui répondent aux appels d’offres et lui transmettent les projets à piloter. Il aura pour mission principale d’assurer l’orchestration complète des projets afin de garantir le respect des engagements contractuels et des délais impartis.
Ses principales responsabilités incluent :
Assurer la gestion globale du projet depuis la réception jusqu’à la livraison.
Coordonner les différentes parties prenantes (clients, fournisseurs, production, logistique).
Suivre et valider chaque étape du projet en garantissant la qualité et la conformité des livrables.
Veiller au respect des délais et du budget alloué.
Maintenir une communication fluide et efficace avec les clients internationaux.
Qui êtes-vous ?
Diplôme d’ingénieur.
Expérience de 2 à 3 ans minimum en gestion de projet industriel.
Compétences commercial et en relation client
Expérience en environnement PME, nécessitant autonomie et polyvalence.
Maîtrise de l’anglais (clients internationaux).
Que pouvez-vous espérer ?
Ce poste constitue une opportunité unique d’évoluer dans un environnement dynamique et international, au sein d’une entreprise reconnue pour son expertise dans le domaine du contrôle d’accès.
Our partner is looking for an In vivo Principal Scientist to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Collaborate across project teams to establish scientific in vivo strategy and study plans for drug discovery projects.
Serve as the in vivo pharmacology lead for several drug discovery projects. Ensure that projects have all critical in vivo data to enable project stage dependent decisions.
Work within multi-functional teams to support target identification, validation within the drug discovery process.
Work across the in vivo team in a highly collaborative manner, sharing expertise and resources to meet study needs across In Vivo Pharmacology.
Design and conduct in vivo studies to evaluate and establish efficacy, PK/PD relationship, combination strategy, biomarker identification and analysis.
Develop and characterize new in vivo mouse models and techniques.
Ensure team members comply with all regulatory requirements and internal policies (Ethics, HSE).
Interpretation, presentation, and documentation of experiments as well as preparation of reports. Written and verbal presentations of results within a multidisciplinary team environment.
Contribute to relevant in vivo sections of study reports and regulatory documents e.g., IND filings, patent.
Networking: develop external network and manage external collaborations.
Your profile?
Degree: PhD or equivalent experience in a relevant scientific field
In vivo experience: Extensive hands-on experience with in vivo studies and associated experimental techniques
FELASA C certification
Team spirit: Strong ability to collaborate effectively within a team and work in a cooperative environment.
Language skills: Intermediate level or higher proficiency in English
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.
Project Manager Validation Your responsibilities ? • Responsible for the coordination of the validation of small projects linked to eCC Secondary (Formulation or Filling) related to equipment such as freeze dryer, autoclaves, isolator…or CIP, SIP, Mediabulk, Mediafill, Mediaform or utilities (EDI, EPI, EUF, VP, ACP, N2) or process control/automation equipment. • Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards. • Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to eCC or projects • Review and approve protocols and reports and check-lists and risk assessment related to validation • Manage deviations and out of specifications and CAPAs : bring expertise and help in investigating and solving issue Manage documentation SOP/ OF and master data needed for the project
Your profile ? Basic qualifications: – University degree in sciences – Validation – Change control management – At least 3 years experience in Supply Chain activities (production, – QC, QA, Validaton) in a global environment. – GMP knowledge – Knowledge of regulatory – Knowledge of Bio processes – Knowledge of Bio vaccines Preferred qualifications: • Validation expertise • Change management • eCC expertise • P&P or similar experience/expertise
