QA Head

Aishwarya Healthcare; Sikkim; On-site; INR 2,000,000 - 3,200,000; Full time

Job summary

Aishwarya Healthcare in India seeks a seasoned QA Head for Sterile Injectables to lead the Quality Assurance function, ensuring GMP compliance, robust QMS, batch release, and audit readiness. You will drive continuous quality improvements and regulatory readiness across manufacturing and laboratories.

Ideal candidates hold M.Pharm or MSc with 10-15 years of pharmaceutical QA experience, including sterile injectables, and demonstrated leadership in audits (WHO-GMP/CDSCO).

Qualifications

• Must have M.Pharm or MSc with 10-15 years of pharmaceutical QA experience, including sterile injectables.
• Strong experience in QMS, batch release, and regulatory audits.
• Hands-on exposure to WHO-GMP/CDSCO inspections.

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.

Skills

QA leadership

QMS

Batch release

Regulatory audits

Team management

Education

M.Pharm or MSc

Job description

QA Head- Sterile Injectables

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.

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.
• Strong 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.