Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Post : QA-Validation
Designation : Executive/ Sr Executive
Reporting to : QA Head
Job location : Ankleshwar Unit 1
Min. career experience : 3 - 10 Yrs
Min. Zydus tenure : 2 Years
Technical skills required : Documentation , compliance ,
Soft skills required : Analytical Thinking , Communication , collaboration , Attention to details
Job Description
• Review of Process/Cleaning Validation Protocol and Report.
• Review of Validation BMR and PCR
• Review of the Equipment Verification qualification documents, Periodic review report, Performance requalification and Annual utility review reports
• Review and impact assessment of changes related with equipment, utility and project work initiated in-track wise.
• Review of qualification documents i.e. URS, DQ, IQ, OQ and PQ for equipment’s, facility and utility and participate in execution of the same.
• Review of Qualification document of compressed air, nitrogen gas, water.
• Review and approval of equipment instrument calibrations and equipment Preventive Maintenance in SAP module.
• Review of Breakdown Maintenance in SAP and Relevant Trend report
• Participation for preparation and review of risk assessment for equipment, facility, utility, Nitrosamine & Azido Impurity.
• To review the Alarm challenge test of GXP process control system and Relevant Trend report
• To perform System Audit trail review for the Manufacturing and Engineering GxP System.
• Usage decision for of the recovered solvent, Intermediate, Drug Intermediate and Drug Substance.
• To prepare the schedule of periodic review of GXP application system installed at manufacturing facility.
• To verify the individual System Access Control in Manufacturing and utility Equipment
• To review the protocol for Computerized system retirement / Decommissioning.
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