Job Description

Head of Quality Assurance (Pharma)Position:

Head - Quality Assurance (QA)

Department:

Quality Assurance

Reports To:

Managing Director / Plant Head / VP - Quality

Location:

Nalagrah HP

Role Summary

The Head of Quality Assurance is responsible for leading the QA function to ensure that all pharmaceutical products are manufactured in compliance with

cGMP, regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO, etc.)

, and company quality standards. This role oversees

quality systems, documentation, audits, training, compliance, and continuous improvement initiatives

to maintain a state of inspection readiness at all times.

Key Responsibilities

Quality Systems & Compliance

Establish, implement, and monitor Quality Management Systems (QMS) in line with global regulatory requirements. Ensure compliance with

ICH, WHO, USFDA, EMA, MHRA, CDSCO, and other regulatory guidelines

. Oversee

change control, deviations, CAPA, OOS/OOT, risk management, and product quality reviews

.

Documentation & Records

Approve

SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs)

, and quality policies. Maintain data integrity and electronic documentation compliance.

Audits & Inspections

Prepare the site for

regulatory and customer audits/inspections

. Lead internal audits and vendor audits; ensure timely closure of audit findings.

Team Leadership & Training

Lead and mentor the QA team, ensuring continuous training on GMP and quality standards. Foster a culture of compliance, integrity, and continuous improvement.

Product Quality & Release

Ensure timely review and approval of batch manufacturing and analytical documents. Authorize batch disposition/release in compliance with regulatory requirements.

Cross-functional Collaboration

Work closely with Production, QC, R&D, Supply Chain, and Regulatory Affairs teams. Provide QA support for

technology transfer, validation, and new product launches

.

Continuous Improvement & Risk Management

Drive initiatives for operational excellence and quality improvements. Implement

Quality by Design (QbD)

and risk-based approaches in manufacturing.

Qualifications & Experience

Education:

M. Pharm / B. Pharm / M.Sc. (Chemistry / Biotechnology / Microbiology).

Experience:

Minimum

15+ years

in Quality Assurance/Quality Control in the pharmaceutical industry, with at least

5 years in a leadership role

. Strong knowledge of

global regulatory requirements (USFDA, EU, MHRA, WHO, TGA, CDSCO, etc.)

. Proven experience in handling

regulatory inspections and audits

. Excellent leadership, communication, and decision-making skills.

Key Competencies

Strong understanding of

cGMP, GLP, GDP

. Leadership and people management. Analytical thinking and problem-solving. Strategic planning and execution. Inspection readiness and compliance mindset.
Job Type: Full-time

Pay: ?80,000.00 - ?90,000.00 per year

Benefits:

Food provided Health insurance Provident Fund
Work Location: In person

Speak with the employer

+91 7657867748