
CSV Validation Specialist
il y a 14 heures
About Our Job
We are seeking a skilled CSV validation engineer to join our exciting project for a leading pharmaceutical company.
The successful candidate will work on the validation of pharmaceutical machinery used in tablet production, ensuring that the systems are compliant with regulatory requirements.
Responsibilities and Expectations:- Perform CSV validation of computer systems used in pharmaceutical production.
- Develop and execute validation protocols (IQ, OQ, PQ) and ensure all documentation meets GxP and regulatory compliance standards.
- Collaborate with cross-functional teams to ensure that systems are designed, implemented, and maintained in compliance with 21 CFR Part 11 and EU Annex 11.
Requirements:
- 3+ years of experience in CSV validation within the pharmaceutical or biotechnology industries.
- Proficient in computer systems validation (CSV) processes.
- Knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and industry standards for pharmaceutical systems.
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