An urgent interim requirement for a Qualified Person and QA Manager for a leading sterile pharmaceuticals manufacturer based in Hertfordshire.
This is an initial 6-month contract for between 3 to 5 days a week depending on candidate availability. Day rate of £750-950 which could stretch for someone with very relevant product experience.
The business is a leader in its field and partners with global biotech organisations. They are an innovative and highly regarded organisation with multiple sites in the UK and multinational operations. They are busy and growing fast and now need additional QP and QA support.
As Qualified Person and QA Manager, you will:
- Qualified Person release sterile product manufactured on-site
- Quality Systems management across all operations - Approval, change cont., quality improvement and compliance.
- Ensure EU cGMP for all manufacturing operations.
- Promote total quality culture throughout site. Link with manufacturing/QC to improve performance and compliance
- Hosting of external audits and inspections at the manufacturing site and managing responses
- Lead compliance projects and ensure the business meets regulatory commitments
- Co-author, review and authorise the content of APR reports
- Provide technical support for R & D, clinical research and regulatory
The following experience will be essential:
- Extensive experience in the manufacture of sterile pharmaceutical products
- Eligible for nomination as a Qualified Person on the site manufacturers licence.
- Degree level qualifications (or equivalent) in chemistry, microbiology or pharmacy and be a member of a professional body as recognised by the MHRA
- Excellent analytical problem-solving abilities and able to lead by example
This position will be to start in January with interviews ideally taking place before the Christmas break or first week of January latest. Please apply as soon as possible to be considered and we can schedule a call to run through further details. You can also contact James Ivall at Goodman Masson in the first instance.