- 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)
-master degree is required for our QP functions !!
- 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
Are you the new Specialist QA? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com