Qualified Person

Hays
Bewaar Qualified Person
QP | Randstad | Direct Contract | Batch Releases | Project Management | GMP | Dutch Language
Uw nieuwe functie
Responsible for managing a project with a focus on batch release compliance, ensuring all quality, regulatory, and documentation requirements are met to enable timely release to licensed global markets. Lead and oversee a team of Quality professionals within the Quality function. Guide, support, and develop the team, fostering high performance, driving excellence and continuous improvement.
Working with key personnel (e.g., heads of Production, QC, QA, and Supply Chain), the Senior Qualified Person must ensure the manufacturer/importer operates in full compliance with EU‑GMP (Volume 4), relevant EU directives (including 2001/83/EC and 2011/62/EU), and applicable Dutch legislation The Medicines Act and Opium Act and that public service obligations are met. The Senior Qualified Person must ensure that the company and its activities are in continuous compliance with legal requirements. The Senior Qualified Person must be listed on the company's Manufacturing and Import Authorisation (MIA)
Duties and responsibilities
• Oversee the planning, coordination, and delivery of assigned projects, ensuring objectives, timelines, and regulatory requirements are consistently met.
• Lead New Product Introduction (NPI) activities, including oversight of technological and analytical method transfers.
• Collaborate closely with NPI Project Managers to ensure successful product launches within agreed timelines.
• Manage the qualification and approval of new Contract Manufacturing Organisations (CMOs) associated with new products.
• Perform QP certification for Kenalog and all PCC products, ensuring full compliance with regulatory and quality requirements.
• Provide leadership and direction to team members, ensuring effective performance management, development, and alignment with organisation...