Vacancy number: A2400026
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a QA Officer.
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a QA Officer.
Keywords
- BSc. / HBO
- Quality Assurance
- GMP
- Change controls
- Batch record review
Profile
In this role as QA officer you will support the base business and where applicable support the projects going on, with the responsibility to assure (project) changes are implemented according to cGMP guidelines and quality management systems.You act as a quality expert and apply the Quality Systems to create, review and approve GMP documentation. You will work in close collaboration with other departments (Operations, QC, Planning, R&D etc.).
Responsibilities:
- Paper and electronic batch record review;
- Raw material release;
- Document revisions review and approval;
- Review and approve analytical method transfer protocols and reports;
- Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation;
- Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation;
- Depending on experience supporting master material changes.
Who we're looking for
To fulfill this position, we are looking for BSc. / HBO candidates with a background in bioscience, chemistry, pharmacy or equivalent. You have at least one year of QA experience in the pharmaceutical industry. You are up to date with the current GMP regulations.Other requirements:
- Experience in Change control and all documenting related activities;
- Experience with documentation systems like Trackwise, True Vault is preferable;
- Good communicative and advisory skills in English, both (verbal and written), understanding of Dutch;
- Able to work independently as well as in a team.
Department
As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has an OCP (Operational Commercial Products) and an NPD (New Product Development) & Launch branch. This position will be placed within the NPD group. QA provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for clinical products/process validation batches and support the advanced therapeutic developments at our site.In addition to the base business activities for our products, the company also has a large project portfolio to improve on our processes, implement new technologies, and increase our capacity to be able to deliver future demands.
Company profile
Johnson & Johnson Innovative Medicine is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicine. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), Janssen Biologics is part of the Johnson & Johnson family of companies |
Additional vacancy information
| Reference | : | A2400026 |
| Contract | : | Temporary contract with CLS Services |
| Education | : | HBO/BSc. |
| Employment terms | : | Project for 6 months (maternity leave) 32-40 hours Hybrid role Days of leave: 38 See here our other employment terms for this vacancy |
| Publication date | : | 15-5-2024 |
| Location | : | View location with Google Maps |
| Contactperson | : | Aniek Vugts |
| +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
