Description
My client is seeking a CSV Lead for a 6 - 12 month contract to be based within a Pharmaceutical company within the South - West.Scope of Work & Deliverables
Quality Control (QC) Computer System Validation (CSV) Validation Lead, reporting to the CSV Specialist, providing validation services for various analytical equipment within GMP QC Projects.
Scope includes, but is not limited to:-
Prospective Validation of QC Computer Systems Including a Large Chromatography Data System (Empower 3)
- Generation and execution of validation protocols (IQ/OQ/PQ) and associated summary reports, in accordance with company protocols and procedures
- Generation, review and approval of Risk Assessments in accordance with company protocols and procedures
Review of Legacy QC Computer Systems
- Review of initial validation documentation package
- Review of system risk assessment documents
- Review of system SOPs
- Review of system configuration records
- Review of use of the system in the live environment for compliance with Annex 11 and with 21 CFR Part 11
- Where gaps are identified, arrange and manage the remediation of these gaps
- Additional validation testing of systems where required (IQ/OQ/PQ testing)
- Arrange the update of local SOPs to meet Annex 11 and 21 CFR Part 11 requirements
- Arrange to put computer systems on a suitable review schedule
- Arrange to update computer system details on the computer system inventory
- Manage project schedules including key mile stones
- The generation of Validation Protocols and Reports is also within the scope of this work
- Liaise with user departments (QA, Validation, IT, Vendors and Senior Management) where required
- Provide progress reports to CSV Manager
Key Skills
Extensive knowledge of:-
- GAMP4/5 life-cycle
- FDA 21 CFR Part 11
- EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines "Annex 11 (Computerised Systems)"
- Extensive knowledge of, and experience in, GMP Analytical QC Equipment qualification
- Extensive knowledge of Full-Life cycle GMP Validation
- Sound knowledge and experience of 'Risk-Based' approach to validation
If this opportunity is of interest please send an updated CV or contact me on