Computer Systems Validation Specialist – Biopharmaceutical – Permanent – South East
Our client is a leading bio-pharmaceutical manufacturer based in the South East. At present they are seeking a Computer Systems Validation Specialist to take ownership of the validation life-cycle for computerised systems (including GMP automated systems and IT based systems).
- Responsible for developing and managing the site strategy towards CSV.
- Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
- Develop and manage risk based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
- Support vendors to ensure adherence to, and application of GAMP.
- Manage risk based execution to ensure test data may be leveraged from commissioning testing into qualification.
- Ensure that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
- Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
Required skills and experience:
- Good understanding of the implementation of the requirements of GAMP 5, adherence with 21CFR Pt11, EU GMP Annex 11.
- Significant experience of validation within a parenteral (bio) pharmaceutical or blood products manufacturing environment (API and/or fill/finish).