Senior Executive

Drlogy; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Drlogy is seeking a Senior Executive for Quality Assurance in Ahmedabad. This role involves supporting QA activities for OSD operations, ensuring compliance with quality standards and managing documentation processes.

The ideal candidate will hold a B.Pharm or M.Pharm and have 8–12 years of relevant experience in Quality Assurance. Responsibilities include reviewing QMS documentation and leading internal audits, ensuring a focus on quality and compliance.

Qualifications

• 8–12 years of experience in QA OSD.
• Strong knowledge of QMS and GMP practices.
• Experience with change control and compliance checks.

Responsibilities

• Manage Quality Assurance activities related to OSD.
• Review QMS documents and monitor compliance.
• Prepare quality reports and support audits.

Skills

Quality Assurance

QMS Documentation

GMP Compliance

Risk Assessment

CAPA

Education

B.Pharm or M.Pharm

Job description

Senior Executive – Quality Assurance (OSD)

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.

Qualifications

This requires B.Pharm or M.Pharm qualification with 8–12 years of QA OSD experience.

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 elevate appropriately.
• Guide team members on QA documentation, QMS workflow, and SOP compliance.
• Support compliant, audit-ready, and quality-focused QA operations.