Senior Associate Plant – QA
For one of our bio-technical companies, we are looking for a Senior Associate Plant – QA. You will be working in 3 shifts, early, late and night shift.
You will be providing guidance and support in the production area at ABR in regard to compliance with SOPs and work instructions. You will be performing batch record review of batches assembled, packaged, and labeled at ABR and contract manufacturers.
- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
- Review and approve batch production record data entries before production activities take place
- Perform finished product checks during (commercial) production runs
- Review and approve deviation records, Initiate, and own deviations as needed.
- Approve Maximo Work Orders
- Review and approve test protocols before use in production
- Perform GMP compliance checks in production
- Assist in development and delivery of GMP training activities for QA and production staff
- Assist in various investigations as needed
- Responsible for preparation of weekly/monthly metrics
- Own and maintain departmental performance boards
- MBO or bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
- 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. (Big Plus)
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
- Manufacturing and/or Quality analytical processes and operations.
- Location: Breda, Netherlands
- Full time, on site
- Shift work: 3 shifts: early: 06.30-15.00, late: 14:30-23:00, night: 22:30-07:00
- 1 year contract high possibility of extension
For further information, please contact Talitha van Romondt at +31 (0)20 20 44 502 or email at email@example.com