We are actively looking for an enthusiastic and experienced QA Specialist.
- ... have a pharmacist degree (or a scientific degree)?
- ... have experience with GMP and GDP?
- ... have a first experience in dealing with non-conformances and change control records?
Did you say yes to this three questions? Then you are the person we are looking for!
- Provide daily oversight, guidance and support to Production staff in regards to compliance with Quality Policies and Procedures.
- Disposition batches labeled and packaged at ABR
- Handle Non Conformances and CAPA’s mainly as initiator or QA-contact. Lead and assist in various investigations as needed.
- Own, review and approve SOP’s
- Handle change control records mainly as assessor or as QA contact
- Participate in ABR projects and improvement efforts including product launch teams
- Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements.
- Perform GMP compliance checks in production
- Assist in development and delivery of GMP training activities for QA- and production staff.
- EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
- Typically 3+ years of related professional experience Relevant experience in dealing with Non Conformances and Change Control records
- Good problem solving skills
- Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
- Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
- Customer oriented and service minded
+32 15 21 11 04