CSV Specialist
CSV Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Required Technical Skill Set.
- Desired Competencies (Technical/Behavioural Competency).
- Knowledgeable in 21 CFR Part 11 Annex 11 and GAMP 5.
- Updates validation procedures including change control training and audits to ensure the maintenance of system validation.
- Writes and reviews technical validation documents (e.g. validation plan URS FRS Risk Assessment Traceability Matrix IQ/0Q/PQ/OPQ protocol report etc.).
- Assists in system validation project activities (e.g. writing protocols reviewing/approving test scripts drafting validation reports etc.).
- Review and approve Change Control requests and assess the impact on system validation status.
- Review and approve procedures forms and manuals.
- Perform audit trail reviews and document results.
- Perform system validation status evaluations and complete reports.
- Assist with supplier qualification assessment data gathering.
- SN
- Responsibility of / Expectations from the Role.
- Selected associates would be required to work closely with Custom Leadership team to understand current CSV implementation New customer onboarding and plan strategy to ensure CSV compliance.
Employment Type
Full-time
