QP - IMP (Investigational Medicinal Products)

Qualified Person - IMP (Investigational Medicinal Products)

Are you a driven and detail-oriented professional looking to make a significant impact in the pharmaceutical industry? Our client, a leading organisation in the field, is seeking a Qualified Person (QP) for Investigational Medicinal Products (IMPs) to join their dynamic team in the Netherlands. If you have a passion for quality assurance and regulatory compliance, this is the perfect opportunity for you!

Key Responsibilities:

As the QP for IMPs, you will play a crucial role in ensuring that investigational products meet the highest quality and safety standards.

Your key responsibilities will include:

• IMPs Release and Certification: Certify the release of IMPs for clinical trials, ensuring adherence to EU GMP Annexe 13 requirements and product specifications.
• Quality Oversight: Provide quality oversight for manufacturing, testing, and distribution activities, ensuring compliance with GMP and Good Clinical Practise (GCP).
• Documentation Review: Review and approve batch manufacturing records, validation protocols, and analytical data to verify compliance with GMP requirements.
• Regulatory Compliance: Stay updated on evolving EU and international GMP regulations, providing guidance and support to project teams.
• Training and Development: Mentor Quality Assurance staff and cross-functional team members on GMP requirements for IMPs.

Qualifications:

We're looking for candidates who possess the following qualifications and experience:

• Education: Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or a related field.
• QP Certification: Must be a certified Qualified Person (QP) recognised under EU Directive 2001/20/EC with experience in IMP certification.
• Experience: A minimum of 5 years in Quality Assurance or a similar role within the pharmaceutical industry, with a focus on IMPs.
• Technical Skills: Strong problem-solving and analytical skills, excellent written and verbal communication in English, and the ability to manage multiple priorities in a fast-paced environment.

Preferred Skills:

• Experience with regulatory inspections (eg, EMA, MHRA).
• Familiarity with quality management systems (QMS) and electronic documentation systems.