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 with approved protocols and regulatory expectations.

Documentation Control

- Approve and authorize:
- SOPs
- Specifications
- Validation Protocols
- Validation Reports
- Master Documents
- Quality Policies
- Controlled Formats
- Amendments and revisions.

- Ensure effective document control and data integrity practices.

Quality Control & Microbiology Oversight

- Oversee Quality Control Laboratory operations.
- Review microbiological monitoring activities and environmental monitoring trends.
- Ensure timely review of analytical data and laboratory investigations.
- Monitor laboratory compliance with GLP and data integrity requirements.

Audit Management

- Lead and coordinate:
- Regulatory inspections
- Customer audits
- Internal audits




- Supplier audits

- Ensure audit observations are effectively investigated and CAPAs implemented.
- Monitor audit compliance status and effectiveness.

Risk Management

- Lead Quality Risk Management activities.
- Ensure risk assessments are scientifically justified and documented.
- Drive risk-based decision making across manufacturing and quality operations.

Regulatory Affairs Support

- Coordinate with Regulatory Affairs for:
- Dossier review
- Regulatory submissions
- Product registrations
- Agency responses
- Deficiency responses.

- Support regulatory inspections and agency communications.

Training & People Development

- Ensure induction and continuous GMP training for all Quality personnel.
- Identify competency gaps and implement development plans.
- Conduct performance reviews and coaching for direct reports.
- Build a high-performing quality team through mentoring and succession planning.

Customer & Business Support

- Communicate with customers regarding quality and technical matters.
- Support technical discussions with business partners.
- Participate in technology transfer and new product introduction activities.
- Support cross-functional teams for business continuity.

Continuous Improvement

- Identify opportunities for process improvement.
- Lead quality excellence initiatives.
- Promote Lean, Six Sigma, and continuous improvement practices.
- Improve Right First Time (RFT) performance and reduce quality deviations.

📌 Quality Head (Ahmedabad)
🏢 Abaris Healthcare
📍 Ahmedabad