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