Position Title: General Manager Quality Assurance (Site QA Head)
Location: Baska, Halol, Gujarat
Company: BDR Pharmaceuticals International Pvt. Ltd.
Reporting To: Corporate Quality Head
Experience Required: Minimum 20+ years in pharmaceutical Quality Assurance, with at least 5 years in senior leadership managing injectable and OSD QA operations
Educational Qualification: M.Pharm / B.Pharm / M.Sc (Pharmaceutical Sciences / Chemistry or related field)

Position Overview

The General Manager – Quality Assurance will lead and oversee the entire QA function for the Baska manufacturing facility, which includes both General Injectable and General OSD units. This role carries full responsibility for ensuring compliance to cGMP, international regulatory standards, internal quality standards, and data integrity principles. The role also involves strategic leadership for audit readiness, QMS strengthening, and cross-functional collaboration to ensure quality-driven site operations.

Key Responsibilities

1. Site Quality Leadership
- Lead, manage,



and enhance all QA operations for both Injectable and OSD manufacturing blocks.
- Establish and maintain a robust Quality Management System (QMS) aligned to cGMP, USFDA, EU GMP, WHO, TGA, and other regulatory expectations.
- Act as Management Representative (MR) for quality during internal, external, and regulatory inspections.

2. Compliance Management
- Ensure site-wide compliance with global regulatory requirements and internal SOPs.
- Oversee audit readiness and lead all regulatory inspections (USFDA, EU GMP, MHRA, WHO, ANVISA, TGA, etc.).
- Drive effective and timely closure of audit observations, CAPA management, and compliance enhancements.

3. Quality Management System (QMS) Ownership
- Oversee deviation management, change controls, CAPA systems, risk assessments, investigations, and batch release processes.
- Manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
- Drive cont

📌 Site Head Quality Assurance (Halol)
🏢 BDR Pharmaceuticals
📍 Halol