Executive - CSV - Quality Assurance

3 - 7 years

4 - 6 Lacs

Posted:3 weeks ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  1. Excellent experience of computerised system validation as per 21 CFR part 11, CFR part 211, Annexure 11, GAM5 etc.
  2. Good experience in preparation, review of validation protocol and report of URS,FRS, IQ/OQ/PQ/Requirement Traceability Matrix of system software
  3. Change management system, deviation, risk assessment , Impact analysis and Gap assessment review knowledge.
  4. Good knowledge of good documentation practices, instruments and softwares used in lab and manufacturing like SAP, Trackwise, SCADA etc.
  5. Known about life cycle approach of computerised system and backup system.
  6. Preparation and monitoring of validation master plan and schedules
  7. Review of audit trails and explain ability of validation activity.

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Alembic Pharmaceuticals logo
Alembic Pharmaceuticals

Pharmaceuticals

Vadodara

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