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Data Integrity Specialist
2 months ago
PM Group is seeking a skilled professional to join our team as a Validation Specialist.
Key Responsibilities:- Review and Analysis: Conduct thorough reviews of DIRA (data integrity risk assessments) to identify data integrity risk-level and data control shortfalls.
- Validation Documentation: Review VDS (validation determination statement) documents to familiarize with the validation deliverables for each equipment control system being upgraded.
- Systems Upgrade: Execute systems upgrade work as required, including URS, DQ, validation planning, validation protocol review/writing, execution of CSV, writing FVR (final validation report), and writing RTM (requirements traceability matrix).
- Procedure Development and Training: Assist with procedure writing and retraining of system users.
- Project Planning: Provide project planning services as required to assist the OT & automation manager with the upgrade project.
- Experience: Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors.
- Technical Competence: Successful candidates will be able to demonstrate technical competence, work efficiently and safely, and be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable.
Working Arrangements: Onsite, 6 months, Outside IR35
