QA Head (OSD)

QA Head (OSD)

Experience:

Qualification:

Location:

Salary:

Please send your resume/cover letter to [HIDDEN TEXT]

Responsibilities

1. Lead regulatory inspections including WHO-GMP, CDSCO, EU-GMP, PIC/S, MHRA, USFDA, and customer audits.
2. Ensure full site readiness and drive timely closure of audit CAPA.
3. Oversee implementation and monitoring of the Quality Management System.
4. Review and approve deviations, CAPA, OOS, OOT, change controls, and market complaints.
5. Supervise APQR/PQR preparation, review, and approval.
6. Review and approve Master BMR/BPR, MFR, SOPs, validation protocols, and reports.
7. Direct batch release processes, line clearance, and compliance in manufacturing and packaging areas.
8. Ensure qualification and validation activities meet regulatory expectations (process, cleaning, HVAC, equipment, utilities).
9. Monitor environmental conditions, calibration, and preventive maintenance programs.
10. Drive ALCOA+ principles across documentation and electronic systems.
11. Lead GMP and SOP training programs and strengthen the compliance culture.
12. Coordinate with Production, QC, Engineering, Warehouse, SCM, and Projects teams to resolve quality issues.
13. Oversee vendor qualification for RM/PM/API suppliers.
14. Lead and mentor QA teams, manage manpower planning, and drive continuous improvement initiatives.

Skills Required

1. Strong understanding of OSD manufacturing and global regulatory requirements.
2. Expertise in QMS, audits, data integrity, CAPA, OOS/OOT investigations, and root-cause tools.
3. Proven ability to lead regulatory audits independently.
4. Excellent decision-making, communication, and people-management skills.
5. Strong analytical ability with a structured approach to problem-solving.
6. Experience working with regulated-market products.