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Validation Specialist in CSV Compliance
3 months ago
Key Responsibilities
- Assist in the enhancement of equipment and ensure data integrity throughout the project lifecycle.
- Develop and update the Data Integrity Risk Assessment, ensuring all identified gaps are addressed.
- Revise System Category Assessments to reflect the latest equipment details following upgrades.
- Collaborate with the team to produce Validation Plans, Design Qualifications, Failure Mode and Effects Analyses (FMEAs), Final Validation Reports, and Requirements Traceability Matrices.
- Engage directly with documentation processes and submit for validation team evaluation and approval.
- Candidates should possess experience in CSV within the pharmaceutical sector.
- Proven track record in supporting equipment upgrades and maintaining data integrity.
- Successful applicants will demonstrate a high level of technical proficiency.
- Ability to work effectively and safely in a dynamic environment.
- Willingness to mentor and train colleagues in specialized areas of expertise.
- Comprehensive understanding of the full CSV lifecycle documentation.
Outside IR35
Duration: 4-6 months project
