QA Specialist/ QP Qualified Person

Our client, a well-known pharmaceutical manufacturer, is currently seeking a QA Specialist to join them at their site in Breda. The successful candidate will be either a Qualified Person (QP) or a Responsible Person (RP).

Main tasks:

• 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.

Minimum Requirements

• 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

Preferred Requirements

• Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
• Customer oriented and service minded