Website Zydus group ltd
Role: OSD Packing – QMS
Position: Senior Executive / Assistant Manager
Job Description:
Company Name: Zydus Healthcare Limited
Industry: Pharmaceuticals
Location: Sikkim Unit II
Qualification: B.Pharm / M.Pharm / M.Sc
Experience Required: 6–12 Years
Job Summary:
We are seeking a highly motivated and detail-oriented professional for the OSD Packing QMS function. The incumbent will be responsible for managing Quality Management System activities, ensuring compliance with GMP, regulatory requirements, and data integrity standards. The candidate should possess hands-on experience in handling deviations, CAPA, change controls, investigations, audits, and quality documentation within a pharmaceutical manufacturing environment.
Key Responsibilities:
Manage and oversee QMS activities for OSD Packing operations in compliance with cGMP and regulatory requirements.
Review and approve SOPs, protocols, reports, specifications, and quality-related documents.
Handle Deviations, CAPA, Change Controls, Risk Assessments, Incidents, and Market Complaints through TrackWise.
Lead investigations, perform root cause analysis, and ensure timely closure of quality events.
Review packing batch records, logbooks, and related documentation to ensure compliance with approved procedures.
Coordinate and support internal audits, corporate audits, regulatory inspections, and customer audits.
Ensure compliance with Data Integrity, GMP, GDP, and Quality System requirements.
Monitor QMS metrics and ensure timely closure of action items and commitments.
Conduct GMP and QMS training programs and support continuous quality improvement initiatives.
Collaborate with Production, QA, QC, Engineering, Warehouse, and other cross-functional teams to strengthen quality compliance.
Required Skills:
Strong knowledge of Pharmaceutical Quality Management Systems (QMS).
Hands-on experience with TrackWise, SAP, and electronic quality systems.
Expertise in Deviation, CAPA, Change Control, Investigation, and Risk Management.
Experience in regulatory audits and inspection readiness.
Excellent documentation, communication, and team management skills.
Sound understanding of cGMP, GDP, Data Integrity, and regulatory guidelines.
Preferred Experience:
Experience in OSD Packing/Manufacturing quality systems.
Exposure to USFDA, MHRA, EU-GMP, WHO-GMP, or other regulatory inspections.
Ability to lead cross-functional quality improvement projects and mentor team members.
