An exciting opportunity has arisen for a Head of Sterile Compliance with my client who manufactures biosimilar monoclonal antibodies at their state-of-the-art facilities in Reykjavik, Iceland.
- To ensure the requirements of the drug product manufacturing schedule are achieved in a safe and cGMP/regulatory compliant manner.
- To be a Subject Matter Expert and key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
- Ensuring the drug product manufacturing suite and equipment is maintained in a state of Inspection readiness at all times.
- Contribute to the smooth technical transfer of new processes/product into manufacturing.
- Act as a lead in the process development, staff training and execution of all activities relating to the aseptic manufacture of drug product including but not limited to visual Inspection, cleanroom behaviours, cleaning, gowning and media fills.
- Act as a lead in the planning and execution of Aseptic Process Simulations including generation of documentation (VPP, Protocol, MBR, SOPs)
- Education: Minimum of BSc in pharmacy, microbiology, biotechnology, biochemistry, engineering or a related field
- Extensive experience in aseptic filling of finished dosage forms for (bio)pharmaceuticals.
- Knowledge of: primary packaging commonly used for parenterals; fill-finish manufacturing processes, cGMP.
- Experience in Media Fill compliance.