Assistant Manager

The Assistant Manager will manage Quality Assurance activities for OSD operations, including QMS, change control, CAPA, deviation, OOS, OOT, risk assessment, documentation review, compliance monitoring, and audit readiness at Zydus Lifesciences, Ahmedabad. This requires B.Pharm or M.Pharm qualification with 8–12 years of QA OSD experience.

Roles & Responsibilities

• Manage QA activities related to OSD manufacturing, packing, documentation, and compliance.
• Review and handle QMS activities including change control, CAPA, deviation, OOS, OOT, and risk assessment.
• Review batch manufacturing records, batch packing records, SOPs, logbooks, and quality documents.
• Ensure production and packing activities are performed as per approved SOPs and GMP standards.
• Support investigation of deviations, quality events, complaints, incidents, and non-conformances.
• Coordinate with production, QC, warehouse, engineering, validation, regulatory, and quality teams.
• Monitor shop floor compliance, line clearance, in-process checks, and documentation discipline.
• Prepare, review, and maintain quality records, investigation reports, CAPA plans, and compliance trackers.
• Support internal audits, regulatory inspections, customer audits, and audit response preparation.
• Ensure data integrity, Good Documentation Practices, and quality system compliance.
• Guide junior QA team members on QMS handling, documentation, and compliance practices.
• Drive continuous improvement, risk-based quality decisions, and audit-ready QA operations.