Location: Netherlands (Hybrid)
COMPANY BACKGROUND:
Our client is a fast-growing pharmaceutical company based out of the Netherlands and is seeking a qualified person (QP) to join our team. We are focused on providing access to a growing portfolio of high quality, niche medicines and orphan drugs to our patients in order to improve health.
MAIN PURPOSE OF ROLE:
The QP will be responsible for ensuring that all pharmaceutical products are manufactured, tested, and released in compliance with relevant regulations and guidelines. The successful candidate will be required to have extensive knowledge of European Union (EU) regulations and guidelines for pharmaceuticals and will be responsible for ensuring that our products meet these standards.
KEY RESPONSIBILITIES:
- Ensure that all products are manufactured, tested, and released in compliance with EU regulations and the Marketing Authorization (including GMP and GDP)
- Act as the main point of contact with regulatory authorities and third-party contractors
- Review and approve all batch documentation, including batch records, analytical data and release certificates
- Manage the release of products for distribution and ensure that appropriate procedures are followed
- Ensure that all deviations and complaints are investigated and resolved in a timely manner
- Ensure that all elements of the Quality Management Systems (QMS) are implemented and maintained in accordance with EU regulations, including relevant procedures, policies and systems
- Responsible for ensuring the Pharmaceutical Quality System (PQS) is established including elements of the Quality Management Systems (QMS) are implemented and maintained in accordance with EU regulations, including relevant procedures, policies and systems
- Provide guidance and training to other members of the quality team
- Responsible for oversight of external partners including conducting audits of manufacturing sites, testing laboratories, and other third-party contractors
- Ensure that all equipment and facilities used in manufacturing and testing are qualified and validated
- Work with other departments, including regulatory affairs, supply chain and commercial to ensure that all processes are compliant with EU regulations and guidelines
PERFORMANCE STANDARDS
- To maintain professional standards always.
- To be punctual, maintain dress standards, be polite and courteous to internal and external co-workers and customers always.
- To adhere to company SOP`s.
