Morgan McKinley are partnering with a leading pharmaceutical company based in the midlands to hire an experienced Computerised Systems Validation (CSV)/ Data Integrity Consultant.
This role is expected to be predominantly/on-site. Some flexibility may be considered, but candidates should be prepared to work on-site as required.
Key Responsibilities
- Lead and support Data Integrity testing and assessment across pharmaceutical manufacturing and control systems.
- Perform 21 CFR Part 11 testing and assess systems against applicable regulatory requirements.
- Conduct data integrity testing of PI Vision and associated process/control system data.
- Assess control system data integrity, including data generation, collection, storage, security, audit trails and retrieval.
- Develop and execute validation and testing documentation in line with GAMP 5 principles.
- Identify data integrity risks and recommend appropriate remediation and controls.
- Review system configurations, specifications, test evidence and supporting documentation.
- Ensure traceability between requirements, risks and test cases.
- Work closely with QA, CSV, IT, engineering, automation and manufacturing teams.
- Ensure activities comply with applicable GxP, FDA 21 CFR Part 11, data integrity and company requirements.
Essential Experience
- Significant experience in Data Integrity within a GxP environment.
- Strong knowledge of GAMP 5 and computerised systems validation.
- Hands-on experience with 21 CFR Part 11 testing.
- Experience testing PI Vision, control systems/automation data integrity testing.
- Understanding of audit trails, electronic records/signatures, access controls and data lifecycle requirements.
- Experience producing and executing validation/testing documentation.
- Strong understanding of FDA and EU data integrity expectations.
