Description
Job Responsibilities:- Provide input into all aspects of validation i.e. from design through to the commissioning and qualification execution phases
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements. Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions during qualification activities.
- Prioritize qualification activities in line with the site schedule.
- Co-ordinate qualification activities with engineering, construction and commissioning activities.
- Co-ordinate qualification activities with contractors and vendors as required.
- Co-ordinate qualification document review and approval.
- Commission and qualify equipment such as skids, vessels, fridges, freezers, incubators, BSC units, isolators as per site procedures.
- Commission and qualify utility systems WFI, Clean Steam, Process Gas, HVAC as per site procedures.
Experience:
- Minimum 5+ years experience in the Pharmaceutical Industry.
- Experience on commissioning, qualifying / verifying some of the following systems: Utilities (water for injection, clean steam, process gases, HVAC), fridges, freezers, LAF, BSC units, autoclaves and isolators.
- Experience writing, reviewing and/or approving commissioning, Verification / qualification test documents and reports.
- Experience temperature mapping would be an advantage
- Knowledge and experience of projects and / or revalidation
- Experience with use of Delta V control systems /PIMs / KAYE Validator