Job Description Quality Head

Quality Leadership
- Provide strategic leadership for all Quality functions including Quality Assurance, Quality Control, Microbiology, Validation, Documentation, and Regulatory Quality Compliance.
- Develop and implement the site Quality Strategy aligned with the company's business objectives and regulatory expectations.
- Ensure continuous improvement of the Pharmaceutical Quality System (PQS).
- Drive a robust Quality Culture across the organization.

Quality Management System (QMS)
- Oversee the effective implementation and maintenance of:
- Deviation Management
- Change Control
- CAPA Management
- Out of Specification (OOS)
- Out of Trend (OOT)
- Risk Management
- Market Complaints
- Product Recall System
- Product Quality Review (PQR/APQR)
- Annual Quality Review
- Supplier Qualification Program
- Self Inspection Program
- Ensure timely investigation and closure of quality events.

GMP & Regulatory Compliance
- Ensure continuous compliance with:
- cGMP
- WHO-GMP
- Schedule M
- FDA requirements (where applicable)




- Other international regulatory guidelines.
- Maintain the plant in a constant state of audit readiness.
- Act as the primary Quality representative during regulatory, customer, certification, and corporate audits.
- Ensure effective closure of audit observations within committed timelines.

Product Quality & Batch Release
- Ensure only products meeting quality requirements are released for distribution.
- Review and approve:
- Batch Manufacturing Records (BMR)
- Batch Packing Records (BPR)
- Batch Release Documents
- Ensure compliance with product release procedures and regulatory commitments.
- Ensure product quality throughout the product lifecycle.

Validation & Qualification
- Ensure timely execution and approval of:
- Process Validation
- Cleaning Validation
- Equipment Qualification
- Utility Qualification
- Computer System Validation (CSV)
- Analytical Method Validation
- Ensure all validation activities comply wi

📌 Quality Head (Ahmedabad)
🏢 Abaris Healthcare
📍 Ahmedabad