Job Description Site QA Head

Oncology OSD Manufacturing Plant

Position Details
- Position: Site QA Head
- Function: Quality Assurance
- Plant: Oncology Oral Solid Dosage (OSD) Manufacturing Facility
- Experience: Minimum 15 years
- Reporting To: Director – Technical Operations
- Team Responsibility: Complete Site Quality Assurance and Compliance Team

Role Objective

The Site QA Head will be responsible for leading the complete Quality Assurance and regulatory compliance function of the Oncology OSD manufacturing facility. The incumbent will ensure that all manufacturing, testing, packaging, validation and support activities are performed in accordance with cGMP requirements, approved quality systems and applicable regulatory standards.

The role requires strong experience in handling USFDA-regulated facilities and prior exposure to Oncology/Cytotoxic OSD manufacturing operations.

Key Responsibilities

1. Site Quality Leadership
- Lead the complete Quality Assurance function covering manufacturing, packaging, warehouse, QC, engineering,



utilities and other support functions.
- Establish and maintain a solid quality and compliance culture across the site.
- Ensure consistent adherence to cGMP, data integrity, contamination-control and regulatory requirements.
- Act as the principal Quality representative for all site-level operational and compliance matters.
- Provide timely quality-related inputs for production planning, product release and business decisions.

2. Regulatory Compliance and Inspections
- Lead the preparation, coordination and successful handling of USFDA inspections and other regulatory audits.
- Handle regulatory agencies and customer audits, including inspection planning, facility walkthroughs, document-room management and response coordination.
- Review and ensure timely closure of regulatory observations, Form 483 observations, warning-letter concerns, audit findings and commitments, wherever applicable.
- Conduct periodic gap assessments aga

📌 Site Quality Lead (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara