Name of the Company - Zydus Healthcare LimitedIndustry - PharmaceuticalsWebsite of the company -Location -Sikkim Unit IIDesignation - Senior Executive/ Assistant ManagerPosition - 1Qualification - B.Pharma / M.PharmaExperience Required - Between 5 - 9 Years of ExperienceRole - QA ComplianceJob Description:1. Implementation, maintenance, and continual improvement of Quality Management System (QMS) in compliance with cGMP, WHO-GMP, and Schedule M requirements2. Execution of QMS elements such as Deviations, CAPA, Change Control, OOS/OOT, Risk Management, Management Review, and Quality Metrics.3. Review, investigation, and approval of planned and unplanned deviations with appropriate root cause analysis using tools like 5-Why, Fishbone, and FMEA.4. Evaluation, approval, tracking, and effectiveness verification of CAPA to ensure timely closure and sustained compliance.5. Preparation, review, approval, issuance, revision, and control of SOPs, policies, manuals, formats, and logbooks in line with Good Documentation Practices (GDP).6. Conducting internal audits, documenting observations, and ensuring timely implementation and closure of audit CAPAs.7. Ensuring compliance with data integrity principles (ALCOA+) for both paper-based and electronic systems.8. Monitoring and trending of deviations, CAPAs, audit observations, complaints, and other quality indicators.9. Preparation and presentation of quality metrics and inputs for Management Review Meetings.10. Coordination with Manufacturing, Quality Control, Engineering, Warehouse, Validation, and Regulatory Affairs for QMS-related activitiesKey Focus: We are looking for the candidates who have exposure in Track wise, SAP, & QMS Tools.
