As Senior QA you assure compliance with regulatory requirements and internal J&J procedures via oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits and data reviews that support company late stage ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Senior QA Associate .
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
The Quality Assurance department at Janssen Vaccines & Prevention in Leiden is a fast-developing department. Janssen Vaccines & Prevention is currently working on a full Vaccine pipeline, developed at our site in Leiden and by external collaborations. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen Vaccines & Prevention. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.
As Senior QA you assure compliance with regulatory requirements and internal J&J procedures via oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits and data reviews that support company late stage development projects. Furthermore, you will support release activities.
- Supplier management including auditing, monitoring and maintenance of Quality agreements suppliers including external manufacturing, laboratories, GMP services and GMP raw material suppliers;
- QA oversight of validation, qualification activities connected to drug substance and drug product manufacturing;
- Assess compliance with regulations for late stage development matters;
- Participate in regulatory agency inspections, (global) project team meetings, and training activities;
- Effective stakeholder manager, able to influence. The ‘go-to’ person on difficult content issues;
- Involved in conception of new ideas with respect to improvement of business processes or procedures;
- Lead the execution of systems aimed at evaluating and maintaining quality and compliance;
- Draft, revise, review and contribute quality assurance guidelines to R&D standard operating procedures;
- Lead process improvements and contributes to the ongoing development of new procedures, techniques and departmental guidelines.
- Prepare batch (DS and DP) dossiers to facilitate technical release.
Who we're looking for
We are looking for an experienced candidate with minimally a MSc in a relevant discipline like Pharmacy or Bio-Pharmaceutical Sciences. You have at least 8 years of experience, of which 5 years relevant to this position (industrial setting/manufacturing and/or Quality Assurance area). As a person, you are pro-active, agile, and enjoys working in a team. Good organizational and communication skills, creativity, problem-solving capabilities and a can-do mentality are key for this position.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 4 months. Contract duration is secure until year-end with no guarantees for extension, however we are looking for candidates for a longer-term commitment. Full time preferred, 32 hours discussable. English required, Dutch not important (vendor contact mainly with Danish and German companies).
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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