Csv Consultant

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PM Group is looking for a CSV consultant to support a pharmaceutical project in the North East
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Responsibilities
- Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
- Generation and execution of Functional & Configuration specifications.
- Generation and execution of URSs.
- Generation and execution of UAT.
- Generation and execution of executing Data Migration documents.
- Generation of Traceability matrix.
- Generation of reports.
- Drafting SOP.
- Requirement analysis and process rationalization.
- Carrying out CSV actions relating to laboratory equipment and small scale process equipment.
- Leading CSV decisions, determining CSV requirements, advising the business on CSV practices, sharing CSV knowledge with the team.
- Validating the introduction of new systems and providing data integrity risk assessments for each.
- User requirement specifications
- Creating design specifications
- Creating functional specifications
- Documentation creation and approval
- Data management tasks, e.g. importing records, sample checking, etc
- Supporting preparation of computerised system documents, validations plans, risk assessments and qualification protocols
- Designing, generating and executing test plans and test protocols
- Project delivery reporting
- Working within a client-led team to deliver a key client project
- Stakeholder management
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**Qualifications**:
Off-Payroll Working Rules

This role is believed to be outside IR35.