Senior Executive

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

Roles & Responsibilities

• Handle Quality Assurance activities related to OSD manufacturing and packing operations.
• Review QMS documents including change control, CAPA, deviation, OOS, OOT, and risk assessment records.
• Review batch manufacturing records, batch packing records, SOPs, logbooks, and quality documents.
• Monitor GMP compliance, shop floor documentation, line clearance, and process adherence.
• Support investigations for deviations, incidents, complaints, quality events, and non-conformances.
• Coordinate with production, QC, warehouse, engineering, validation, and regulatory departments.
• Prepare quality reports, investigation summaries, CAPA updates, and compliance trackers.
• Support internal audits, customer audits, regulatory inspections, and audit readiness activities.
• Ensure Good Documentation Practices, data integrity, and quality system compliance.
• Identify documentation gaps, process risks, and compliance issues and escalate appropriately.
• Guide team members on QA documentation, QMS workflow, and SOP compliance.
• Support compliant, audit-ready, and quality-focused QA operations.