Qualified Person

Walker Cole International is searching for a Qualified Person (QP) to join a well-established Pharmaceutical company as they grow and develop their affiliate in the Netherlands. As the QP, you will be instrumental in acting as a SME to ensure site compliance and performing routine batch release duties of both commercial and clinical small molecule products.

Your responsibilities will be to:

• Act as a QP to release medicinal batches manufactured in accordance with GMP, and application EU/Dutch National laws. 
• To oversee and support self-inspections and audits of 3rd party manufacturers, suppliers and vendors.
• Manage and oversee any deviations that occur to ensure GMP compliance.
• Approve or reject suppliers and manufacturers as required and sign off on any quality contracts

The successful candidate will:

• Be eligible to act as a Qualified Person as per Directive 2001/83/EC.
• Experience working on both commercial and clinical products
• Have a strong ability to work independently in a self-driven and results orientated manner.
• Minimum C1-level Dutch and English language skills

Quality Assurance | QA | Qualified Person | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | Operational | Sterile | Biopharmaceutical | RP | Responsible Person