Drug Product Expert Contracting – Wavre Our client is looking for a Drug Product Expert to join its team. The role involves protocols related activities and communication with stakeholders.
What are the responsibilities? • Activities related to protocols: aligning to a protocol and reviewing protocols, experiments, etc • Communication with stakeholders both internal and external • Interaction with the QA and RA • DP development – development of small molecules, from the first studies to scale up.
Experience and Knowledge requirement Must have • Experience in the pharmaceutical industry • Knowledge of GMP • Fully fluent in English both written and spoken • Proven experience in DP on small molecules
Nice to have • Proven experience in project lead experience • Dosing for injectables • Knowledge of tablet manufacturing
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]
Construction Safety Coordinator – Senior The mission The construction EHS coordinator shall be a competent construction professional, responsible for checking that the project construction activities are executed safely in accordance with the company’s requirements. What are the responsibilities? • coordinate construction activities and liaise with the Host Site EHS team • review safe methods of working ahead of work starting • lead daily safe work planning sessions e.g. SPA, RAMS, PTW • participate in daily prestart workforce safety briefings • participate in safety meetings and lead daily safety walks of the site • participate in toolbox talks • assist in incident investigation • induct / orientate the workers • identify and control new workers • identify general and specific safety hazards to the workers • inspect and conduct safety audits of tasks and safe systems / processes • ensure that all incidents are reported • participate in incident investigations • ensure workers only carry out tasks for which they are trained and qualified • ensure risk assessments and method statements are in place and in use • encourage and participate in the behavioural safety system • intervene and correct any unsafe conditions • participate in safety meetings • ensure good housekeeping and organised tidiness (5S) at all times
Experience and Knowledge requirement • Experince in construction management of medium and large capital projects • EHS experience Soft Skills: • Project and people management skills with thorough knowledge of construction • Communication and collaboration skills
Education, Methodology & Certification Requirements; • University or college training in engineering or EHS • Formal safety professional certification
ICT Skills (software, operating systems, hardware, etc.); MS Office
Language Proficiency Requirements: English – Business French – Fluent
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]
Our partner is looking for a Computer System Validation to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of Technical Change Description
Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the company validation methodology
Who are you ?
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
You speak French and English
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
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.
Our partner is looking for a Project Manager – Business Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Design the project organizational structure and assigns responsibilities. Ensure team members are completing their tasks according to plan.
Contribute to the development of the RFP strategy definition
Support and ensure that local teams are collecting RFP requirements according to plan.
Manages risks on the project through periodic identification with the team and stakeholders, prioritization and manages the countermeasures and/ or mitigation.
Foster relationships between Vaccines and Medicines global teams (Procurement, Engineering, QA, EHS..) and local Engineering/Procurement teams from 6 countries.
Support Global Procurement during the supplier selection process (meeting schedules, action log, minutes of minute, technical and commercial clarification, decision criteria, sourcing approval).
Carries out performance management on the project, escalating issues in a timely manner and reports monthly
Design and deliver solutions and processes in support of project objectives and requirements.
Ensure the overall project plan, timeline, risks and issues are being managed effectively by the teams.
Ensure that the knowledge base (information and people) is developed and maintained, ensuring effective transition of knowledge into the support organisation.
Ensure holistic communications planning ansd stakeholder management approach is in place and active with each site.
Ensure that training needs are identified, defined and delivered accordingly
Participate and support project steering meetings Review outsourcing strategy
Deploy FM contracts, and oversee the transition, mobilization and stabilization phases of the contract deployment with the implementation of monitoring tool, business continuity plan and exit plan
Who are you ?
Ability to work in French and English
Master in Engineering or Business
At least 8-10 years in industrial projects (engineering, maintenance)
Experience in Operation Excellence including Maintenance Excellence
Good knowledge of the international Facility Management market
Knowledge in Procurement process and contract management
Skills in Perfomance Management (LEAN culture, Continuous Improvement)
Proven track record in project management, including global RFPs
Know-how of engineering activities within the pharmaceutical industry
What can you expect ?
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 Methods Validation Bio About our client The new Global Quality (GQC&PQ) organization have the goal to bring innovation, integrated capabilities, and speed to our customers through an empowered team that deliver results and enable network success. Within GQCPQ, the Global Quality & innovation team drives Transversal Innovation through multi-sites feasibility, POC & implementation of new technologies for QC Project is to support the feasibility, fit-for-purpose and business cases of new immunoassays replacing current in-vivo potency for DTaP vaccines. The missions 1. To develop, design, perform & analyse new immunoassays (ELISA, Luminex) (Primary skill). 2. Manage the feasibility & fit-for purpose study including, project management, business case and reporting & communication to different stakeholders (Secondary skill) Primary Tasks & Responsibilities
Manage the feasibility & fit-for-purpose of new immunoassays.
Perform experimental plan, analyse the results, manage the troubleshooting.
Manage lab work (training, stock management, data integrity); Work in GMP lab environment.
Feasibility, fit-for-purpose, and method development design.
Demonstrated proficiency one or more of the following areas:
Immunoassay development, validation (for QC)
Project management
Lab activities
Data analytics (including calculation method)
Preferably minimum 3 years’ experience in the Pharmaceutical Industry with proven lab activities management of and project management
Capability of working independently and ability to prioritize tasks and meet strict deadlines.
Knowledge
The activity requires a broad and thorough knowledge of immunoassays including development, validation and method troubleshooting.
Strong interest and experience in immunoassay and scientific software development
Experience in software use (SoftMaxPro, Combistat, PLA, Gen5,…)
Soft Skills: · Strong problem-solving skills, profound background in scientific analytical method · S/he will be well organized, open-minded, able to work on different projects in parallel, and have a project-orientated spirit. · S/he should have good communication skills in English and an open, proactive personality to work in a team of young international researchers.
Excel or other soft for data analysis (tab, graph, basic statistic) Familiar with MS Office package
Language Proficiency Requirements · English Fluent · French 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]
Ensuring quality for the validation part in the relevant projects (e.g., PUPSIT, RTU, …)
Conducting QA Oversight of validation activities
Actively participating in defining validation strategies in collaboration with project/validation teams and in compliance with GS requirements
Reviewing and approving all documentation related to validation (URSFMEA-LRA-CRA-DQ-IOQ-PQ-Leveraging Reports)
Participating in deviation investigations and troubleshooting
Key responsibilities:
Reviewing and approving all documentation related to the projects under their responsibility: validation plans, validation summary reports, URS, FMEA, Leveraging Reports, IQOQ protocols and reports, PQ protocols and reports, CRA, LRA
Actively participating in the project and process design phase to understand the project and establish an appropriate implementation and validation strategy
Establishing workload planning based on project schedules
Ensuring the chronological and logical execution of validation activities
Actively participating in project follow-up meetings, troubleshooting, and addressing various issues to anticipate validation impacts or risks and contribute to developing solutions
Ensuring QA Oversight of implemented methods
Providing coaching/transferring/handover of knowledge related to different projects
Your profile ?
Engineer or university degree in biotechnology, agronomy, chemistry, pharmacy, etc.
Minimum of 5 years of experience in an aseptic laboratory/industry, quality, or production environment
Experience in a regulated environment such as cGMP
Experience in industry validation; and in specific documents: URS, FMEA, Leveraging Reports, LRA (L=Leachables), CRA (C=Compatibility)
Knowledge of IPV (In-Process Verification) and PA (Proces Analytical Technology) processes is a plus
Advanced knowledge of aseptic technologies, closed systems
Experience as a QA Validation professional
Knowledge of GMP and aseptic environments
Our offer ?
We offer you a permanent contract and an attractive salary package. You'll also benefit from the opportunity to develop personally and professionally through in-house training. If you're interested, don't wait any longer!
Support the overall Warehouse and Distribution Excellence (WADE) management team to succesfuly transfer its activities to new facilities.
The focus will mainly be on supporting our Warehouse Manager Operations and our Global Performance System (GPS) Lead in their daily activities in order to enable them to focus on the activites related to the new facilities.
Main activities:
Operations
Responsible for securing and role modelling a safe and healthy environment as per company's standards
Manage raw materials and vaccines shipments to internal and external customers as per applicable regulations
Ensure compliance of operational activities with GXP, quality, training, EHS and security requirements.
Provide support to compliance activities (CAPA/Deviation management, training coordination, L1 audits, etc.)
Participate to the relevant governances, meetings workshops where needed
Escalate to the Wade leadership team any issue not allowing a smooth management of the above items.
Continuous Improvement
Manage the deployment of continuous improvement initiatives in accordance with our GPS master plan
Manage the orchestration of our project portfolio, including project prioritization and progress monitoring
Support the operational team in implementing an effective performance management system
Participation to the relevant governances, meetings workshops where needed
Escalate to the Wade leadership team any issue not allowing a smooth management of the above items.
Your profile ?
Bachelor degree or equivalent
Min. 5 years experience in manufacturing/distribution within the vaccines industry (i.e. ideally in Logistics)
Strong continuous improvement background
Strong project management background
Fluency in French and English
Excellent communication skills
Proven agility/adaptability to changing environment
Our offer ?
We offer you a permanent contract and an attractive salary package. You'll also benefit from the opportunity to develop personally and professionally through in-house training. If you're interested, don't wait any longer!
Our partner is looking for a QA GDP to join its team. The purpose of the mission is to support the Quality for Supply Chain team, being a quality partner for some of the distribution related activities. The mission also consists in supporting the operational quality assurance management of Wade Distribution Center. The objective is to ensure the continuous supply of vaccines in line with regulatory, quality and business objectives to meet customer needs.
What are the responsibilities? Quality partner for deviations: • Be the QA representative for CAPA on Wade operations, ensuring those are properly performed, following relevant procedures. Ensure implementation follow up is performed and escalation process is properly applied when needed. • Support the monitoring of quality KPIs for Wade distribution center related activities through the preparation / lead of the monthly quality governance meeting (Quality Council). Ensure that periodical reviews are performed, and negative trends are properly remediated and escalated as required. • Support archiving management of QA documents in Wade • Review and approve self-inspections performed by Wade operations and ensure appropriate actions are identified to address the observations. Ensure follow up of the action plan. Perform self-inspections of the department activities following the self-inspection planning, ensuring due date are respected. • Act as QA reviewer for procedures / ways of working. Be the QA representative in the Wade weekly SOP governance meeting an ensure the planning of review is realistic. Perform SOP / WOW QA review accordingly and ensure comments are discussed and implemented. • Support update/review of the department owned SOPs. • Coordinate monthly KPI meeting: extract data, prepare slides, align with stakeholders as needed. • Promote continuous improvement mindset in a day to day activities within the team and peers by using Operational Excellence tools (e.g.:IPO/PSS/Fishbone/5S…) • Participate in the management of team performances through regular shopfloor presence • Coordinate DRA (Distribution Risk Assessment) performance with relevant stakeholders, ensuring adherence to the plan. • Coordinate WDA (Warehouse Distribution Authorization) qualification process (i.e. pre-work with LOCs, WDA pre-assessment before upload to Veeva) • Collect inputs from relevant stakeholders to be shared with the auditing team for Audits to LOCs. • Rixthermo centralised mailbox: filtering, analysing mails received to prepare Tier meetings
Your profile ?
• 3-5 years of experience as QA in a pharmaceutical /biological production environment • Scientific background is required • Knowledge of Good Distribution Practices, including cold chain management. • Risk based approach methodology adept • Knowledge of regulatory, GMP, GDP and legal requirements relating to QA needed. • Good knowledge and expertise of quality systems, e.g. CAPA, Documentation Management, Training • Demonstrated capabilities in SAP • Fluency in French. Full level of English written and spoken • Good communication skills, proactiveness, independency, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence • Easy collaborative & networking capabilities • Agile mindset • Result-oriented – delivery on time • Team player
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]
CSV – IT Business Manager #CSV #IT #Manager #Pharma #GMP #CDI Vous êtes orienté CSV – IT et people management ? Vous avez d’excellentes connaissances des normes pharmaceutiques ? Alors ce qui va suivre va vous intéresser ! Notre partenaire, une entreprise pharmaceutique du Brabant Wallon, recherche un CSV – IT Business Manager Quelles sont vos responsabilités ? Gestion de l’équipe Business IT dans un environnement GMP
Gestion du personnel (soutien, évaluation, embauche).
Organisation de l'équipe et attribution des projets/tâches aux membres de l'équipe.
Participation aux audits des clients et aux inspections des autorités.
Définition des priorités en collaboration avec les responsables opérationnels.
Gestion des projets de validation de systèmes informatisés en environnement GMP
Planification détaillée du projet et des équipes de projet.
Gestion des budgets.
Coordination du projet.
Collaboration avec les services informatiques régionaux pour l'élaboration et la mise en œuvre des projets.
Représentation pour les projets pluridisciplinaires
Gestion des URS et les spécifications fonctionnelles.
Définition de plan de validation/test/protocoles.
Gestion de l'exécution des tests.
Rédaction des rapports et des procédures de validation.
Gestion des révisions périodiques.
Gestion du support fonctionnel aux applications
Définition des super user et des back up.
Gestion des change control et de l'interface avec l'informatique régionale.
Qui êtes-vous ?
Vous possédez un Master ou PhD scientifique et vous avez une affinité pour l’IT.
Vous avez une expérience confirmée en tant que chef de projet de validation dans l’industrie pharmaceutique.
Vous avez de très bonne connaissance de la validation des systèmes informatiques, du GAMP, du 21 CFR Part 11 et d'autres réglementations connexes.
Vous maitrisez le français et l’anglais.
Vous avez de l’expérience en gestion d’équipe.
Qu’offre l’entreprise ? Notre client vous offre un package salarial attractif complété d’avantages extra-légaux dont une voiture de société et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant. Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected] Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
You have experience in quality assurance and validation in the pharma sector? You have an eye for details and for work well done? Keep reading your future job description.
Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
As QA Validation, you will Provide QA support and oversight to validation activities according to validation procedures.
To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP)
To define the validation strategies through the change control process
To write and implement some validation documentation (VP, VSR)
To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation)
To ensure the correct application of the validation quality systems on the field and to define improvement plan as required
To support the production & technical services teams in the implementation of the validation activities
To ensure an efficient and compliant CVP implementation
To provide a compliance and business expertise for some specific technical subjects
Challenge, review and approve qualification and validation (IQ,OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the internal standards and procedures
Write some validation (VP, PQ, VSR)
Review Periodic Validation Review documentation according to the company standards and procedures
Ensure timely escalation to Management of critical issues during validation and/or project
Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
Attend all project meetings as QA expert from a compliance point of view the Manufacturing Unit Product & Process, Production and QA Operations for validation topics.
Your profile?
Engineering or scientific background (or equivalent acquired through professional experience)
Experience QA and Equipment’s Validation in a GMP Pharma environment
Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
Use a risk-based approach for problem solving and prioritization of tasks
Blow a quality and compliance mindset through the validation activities
Good communicator, autonomous and rigorous
Team player
Critical mind and quality oriented
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.
