QA Head- Sterile Injectables

Role Summary:

Lead the Quality Assurance function for a sterile injectable manufacturing facility, ensuring compliance with GMP requirements, robust quality systems, batch release, regulatory audit readiness, and continuous quality improvement.

Key Responsibilities

- Manage the site's Quality Management System (QMS), including deviations, CAPA, change control, complaints, and risk management.
- Authorize batch release and oversee review of manufacturing and quality documentation.
- Lead WHO-GMP, CDSCO, and customer audits, ensuring timely closure of audit observations.
- Drive data integrity (ALCOA+) and GMP compliance across manufacturing and laboratory operations.
- Oversee qualification, validation, vendor quality, and training programs.
- Lead and develop the QA team while partnering with Production, QC, and Engineering.

Candidate Profile

- M.Pharm/M.Sc with 10-15 years of pharmaceutical QA experience, including sterile injectables.
- Solid experience in QMS, batch release, and regulatory audits.
- Hands-on exposure to WHO-GMP/CDSCO inspections.
- Proven leadership and team management skills.
- Willing to relocate to Rangpo, Sikkim.

📌 QA Head (Sikkim)
🏢 Aishwarya Healthcare
📍 Sikkim