Quality Assurance (QA) Lead

What will you be doing?

General:

Act as a knowledgeable Subject Matter Expert (SME) for aseptic filling operations within the Albumin plant.
• Provide cross-functional technical support and development to the aseptic filling operations team.
• Mentor and develop supervisors to become SMEs in aseptic techniques and behaviours, offering continued technical guidance.
• Lead the site sterility assurance program, including contamination control strategy (CCS), cleanroom design oversight, aseptic process simulation (APS/media fills), and environmental monitoring (EM).
• Offer expert input on sterile standards and guidelines, including Annex 1 (2023), Annex 15, and the EU GMP Guide.
• Ensure departmental objectives are achieved in alignment with company standards, with a focus on compliance, safety, and reliability.
• Design, update, and monitor training plans covering aseptic filling techniques and behaviours, tracking individu...