You will be working in the European Headquarters of an American Biopharmaceutical international company. This site is handling all distribution, secondary packaging and labelling activities.
You will provide QA guidance and support in the production area.
That includes performing batch record review of batches assembled, packaged and labelled. You will have close contact with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
- Provide daily guidance and support to Production staff
- Act as a first point of contact in case of production queries
- Review and approve batch production record data entries before production activities take place
- Perform finished product checks
- Review of operational SOP’s and Work Instructions as needed; review and approve deviation records
- Initiate and own QA deviations as needed
- Perform GMP compliance checks in production
- Participate in QA production related projects as needed
- Responsible for preparation of weekly/monthly metrics
- Own and maintain departmental performance boards
- Bachelors degree in Life Sciences or related field
- min 1-2 years of experience in a pharmaceutical company
- experience in batch record review and investigations is a plus
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge/ experience is required
- Open to work in 3 shifts
Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.