Zydus Cadila
Location
Ahmedabad | India
Job description
1. Responsible for preparation of theValidation Master Plan, Computer System Validation Master Plan.
2. To prepare and review of DesignQualification, FAT, URS, Validation protocols Reports and Qualificationprotocols reports.
3. To execute and supervise thequalification and Validation activities for equipment, PLC and utility servicesand their continuous performance.
4. To prepare update CleaningValidation Master Plan/cleaning validation / verificationprotocols / reports / matrix.
5. Responsible for ensuring the compliancewith Validation Master Plan and requalification of utility, equipment,procedures and systems as per the frequency described in Validation MasterPlan.
6. To ensure compliance to PreventiveMaintenance Planner for the equipment.
7. To review of calibration certificatesfrom SAP
8. To verify instrument calibration status.
9. To review raw data /audit trail /software (as applicable) at a given frequency to ensure regulatory guidancecompliance.
10. Responsible for preparation of riskassessment and mitigation plan.
Requirements:
Qualification: B.Pharma / M. Pharma / M. Sc
Years of Experience:4-8 years
Experience in Zydus:12/24 months
Experience /Exposure in: Equipment / Utility Qualification and CleaningVerification/Validation
Job tags
Salary
