Head – Quality Assurance (Pharmaceutical Manufacturing)

Location: Sachin, Surat, Gujarat, India

Department: Quality Assurance (QA)

Job Type: Full-time

Industry: Pharmaceutical Manufacturing

Required Experience: 15–20 years

Job Summary

We are seeking an experienced Quality Assurance professional to lead and strengthen the Quality Management System (QMS) at our pharmaceutical manufacturing facility in Sachin, Surat. The candidate will ensure compliance with current GMP, GLP, GDP, GEP, HACCP, applicable regulatory requirements, and corporate quality policies.

The role includes overseeing batch release, validation, CAPA, deviation investigations, audits, documentation, training, stability programs, and regulatory compliance to ensure product quality and continuous improvement.

Key Responsibilities

- Lead and maintain the site's Quality Management System and implement Corporate Quality Assurance policies and SOPs.
- Ensure compliance with applicable GMP and regulatory requirements.
- Oversee batch review and release, deviations, OOS/OOT investigations, CAPA, change control, and risk assessments.
- Review and approve validation and qualification activities, including process validation, cleaning validation, equipment qualification, and calibration.
- Manage document control, data integrity, BMRs, BPRs, specifications,



and other quality documentation.
- Coordinate internal audits, regulatory inspections, customer audits, and corporate compliance assessments.
- Manage vendor qualification, outsourced activities, technical agreements, and regulatory documentation.
- Oversee environmental monitoring, stability studies, retention samples, and contamination prevention.
- Lead and develop QA and IPQA teams through effective training and quality awareness.
- Coordinate with Production, QC, Engineering, R&D;, Regulatory Affairs, Warehouse, and corporate quality teams.

Required Qualifications and Skills

- Relevant degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline, as applicable to the position.
- Relevant experience in pharmaceutical Quality Assurance.
- Strong knowledge of GMP, GLP, GDP, GEP, HACCP, validation, CAPA, audits, and regulatory compliance.
- Excellent leadership, communication, investigation, and problem-solving skills.

Work Location: Sachin, Surat, Gujarat, India Interested candidates with relevant pharmaceutical QA experience and a solid commitment to quality and regulatory compliance are encouraged to apply.

Pay: ₹1,200,000.00 - ₹2,000,000.00 per year

Work Location: In person

📌 Head Quality Assurance (Sachin)
🏢 Globela Pharma
📍 Sachin