Head of Sterile Compliance
A newly founded biotechnology company is currently seeking a Head of Secondary Packaging to join their office in Reykjavik. This organisation is fast becoming a pioneer and leader in the field of biosimilars, with a growing portfolio of developed and manufactured products across the value chain, from cell line development to commercial manufacturing. This position represents an exciting opportunity to work with an already prestigious and dynamic company.
- Collaborating with the Head of DPM and DP Manufacturing team ensure the requirements of the DP manufacturing schedule are achieved in a safe and cGMP/regulatory compliant manner.
- Assisting in the training of staff members, ensuring that Manufacturing Technicians are properly trained for their job functions, and that the training is documented in a compliant manner.
- Acting as 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.
- Acting as an SME author/reviewer and/or approver for written procedures, SOPs etc., in span of expertise.
- Ensuring the DP manufacturing suite and equipment is maintained in a state of Inspection readiness at all times.
- Proactively sharing knowledge for the benefit of others.
- Contributing to the smooth technical transfer of new processes/product into manufacturing.
- Identifying process improvement and waste elimination opportunities to help create and maintain a lean, flexible, and agile manufacturing facility.
- Acting 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.
- Acting as a lead/support in the execution of re-qualification and re-validation protocols to maintain the qualified status of equipment and processes.
- Acting as a lead in the planning and execution of Aseptic Process Simulations including generation of documentation (VPP, Protocol, MBR, SOPs).
- Training, coaching, and mentoring less experienced members of staff.
- Leading in the execution of re-qualification and re-validation protocols to maintain the qualified status of equipment and processes.
Skills and Requirements:
- Minimum of BSc in pharmacy, microbiology, biotechnology, biochemistry, engineering, or a related field.
- A minimum of 10 years' experience in aseptic filling of finished dosage forms for (bio)pharmaceuticals.
- Knowledge of primary packaging commonly used for parenterals, fill-finish manufacturing processes, and cGMP.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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