Senior Executive - Production Zydus Lifesciences

3.0 - 5.0 years

3 - 5 Lacs

ahmedabad

Work from Office

Knowledge of QAMS (Quality Management System). Preparation & review of MPCRs and electronic batch record in software application. Knowledge of preparation and handling of eLog book application. Preparation & review the SOP, Risk assessment and Protocol (e.g. URS/DQ) of various equipment, facility and utilities. Prepare, review the audit report as per regulatory requirements. Handling of Change Control, Deviation and Incident. Root cause analysis and effectiveness of Corrective & Preventive action for Compliance and implementation after recommendations. Preparation of Investigation and impact assessment. Preparation and review of investigation report generated by deviation. Coordination with ...

Posted 2 weeks ago

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Senior Executive - QA Intas

3.0 - 7.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, E...

Posted 1 month ago

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