This position is responsible for assisting the QA Lead and Operational Quality Manager, Supply Chain with the timely review of documentation relating to distribution operations in accordance with relevant schedules and agreed timelines working to both Client Specific and Fisher Clinical Services procedures.
- Assist investigation of deviations associated with packaging, ensuring that issues are appropriately identified and resolved, referring to management where appropriate.
- Pre-approval of distribution study/ component / country additions and amendments.
- Quality documentation - Preparation of new and review of existing Standard Operating Procedures and associated documentation relating to Quality Assurance related processes
- Audits – Assist in internal, supplier and client audits.
- Training – Assist in the training of employees in Quality related processes.
- Perform other duties as requested by line management.
Minimum Requirements/Qualifications (Preferred but not essential):
- Degree level or equivalent in relevant subjects
- Related experience in pharmaceutical GMP
- Experience of working in clinical trials quality/packaging/distribution (IMPs, clinical trials)
- Ability to work with a team providing support to other members
- Ability to work without direct supervision/on own initiative within the remit of the role
- A good knowledge of GMP
- High degree of accuracy, concentration, verbal and written communication