Do you have experience in QA and production, and would you like to take your management skills and capabilities to a higher level? Look no further than this position where you will work in an international high-tech pharmaceutical environment!
In this position your will provide QA guidance and support in the production area. You will perform batch record review of batches assembled, packaged and labeled at the site, and establish effective working relationships with all stakeholders involved Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person
- Initiate and own Minor deviations related to IQA/WH/Complaints Lab activities.
- Regulatory labeling in Warehouse
- Destruction Authorizations
- Own training material related to Quality Processes
- Perform assessments in support of complaint investigations (e.g. Reserve sample inspection, Return sample inspection and Safety Features verification)
- Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted partners to resolve product complaint investigations
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
- MSc or BSc in Pharmaceutical/Life Sciences or related field
- Ideally experience of related Quality Assurance or manufacturing experience in the pharmaceutical (or medical device industry) with experience in batch record review and investigations.
- 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 is a pré
- Fluency in Dutch and English is a requisite
- Salary indication: €3000 - €5000 including allowance on contract. Please contact for ZZP possibilities
- Working hours: Full time, 40 hours
- Region: Breda
- Travel allowance: 19ct/km or Public transport completely covered;
- Vacancy number: 19946
IMPORTANT NOTE: Unlimited EU working permit is required.
Please do not apply if you do not have a working permit to live and work in the Netherlands. Your application will not be processed.