Name of the Company - Zydus Healthcare LimitedIndustry - PharmaceuticalsWebsite of the company -Location -Sikkim Unit IIDesignation - Senior Executive/ Assistant ManagerPosition - 1Qualification - B.Pharma / M.Pharma/ M.Sc. (Chemistry)Experience Required - Between 5 - 9 Years of ExperienceRole - QC-QMS1. Execution of QC-QMS elements including Deviations, OOS/OOT, CAPA, Change Control, Risk Management, and Quality Metrics related to QC.2. Review, investigation, and approval of laboratory deviations, incidents, and atypical results with appropriate root cause analysis3. Review, approval, and monitoring of OOS, OOT, and laboratory investigation reports ensuring timely closure and regulatory compliance4. Evaluation, implementation, and effectiveness verification of CAPA arising from QC investigations, audits, and trends.5. Review and impact assessment of change controls related to analytical methods, instruments, reagents, specifications, stability protocols, and laboratory systems.6. Preparation, review, approval, and control of QC SOPs, specifications, STPs, protocols, formats, and logbooks as per GDP requirements.7. Ensuring compliance with data integrity principles (ALCOA+) in laboratory documentation, chromatographic data, and electronic systems8. Monitoring and trending of QC quality indicators such as OOS, deviations, invalid results, retests, and audit observations9. Preparation, review, and submission of audit responses and CAPA commitments related to QC observations10. Oversight of laboratory controls related to instruments, calibration, maintenance, and qualification documentation.Key Focus: We are looking for the candidates who have exposure in Track wise, SAP, & Computer Knowledge.
