L 3 - Quality Assurance

Job Title: Deputy / General Manager – Quality Assurance

Department: Quality Assurance

Location: Indore Plant

Reports To: Vice President – Technical

Industry: Pharmaceuticals – Regulated Market Manufacturing

Employment Type: Full Time

Position Overview:

The General Manager – Quality Assurance (QA) will be responsible for leading and overseeing all QA functions at the pharmaceutical manufacturing site to ensure compliance with cGMP, regulatory guidelines (USFDA, EU, MHRA, TGA, etc.), and company quality standards. The role is pivotal in establishing a robust Quality Management System (QMS), driving a culture of compliance, and ensuring the release of safe and effective pharmaceutical products.

Key Responsibilities:

Strategic Leadership & Quality Oversight:

Lead the QA department to ensure strict adherence to current Good Manufacturing Practices (cGMP).

Define and implement site-wide QA strategies in line with global quality policies.

Establish robust systems for product quality assurance, documentation, and compliance.

Compliance & Regulatory:

Ensure the site remains audit-ready at all times and leads all external inspections (USFDA, MHRA, EU, WHO, etc.).

Manage responses and CAPA implementation for regulatory inspections and customer audits.

Stay updated with changes in global regulatory requirements and align site practices accordingly.

Quality Management System (QMS):

Oversee implementation and continuous improvement of QMS elements including:

Deviation, Change Control, CAPA, and OOS management

Quality Risk Management

Document and Record Control

Annual Product Review (APR/PQR)

Vendor Qualification and Audits

Batch Release & Documentation:

Review and approve batch manufacturing and packing records.

Authorize batch release as per regulatory and internal requirements.

Oversee document control systems ensuring timely and accurate documentation.

Cross-functional Collaboration:

Work closely with Production, QC, Engineering, Regulatory Affairs, and R&D teams.

Support in technology transfers, process validations, and new product introductions from QA perspective.

People Management:

Lead, mentor, and develop a team of QA professionals.

Promote a quality-driven culture across the site.

Conduct training and competency programs on cGMP and quality systems.

Desired Candidate Profile:

Education:

M. Pharm / B. Pharm / M.Sc. in Chemistry, Microbiology, or related life sciences field.

Experience:

Minimum 15–20 years of experience in the pharmaceutical industry with at least 5 years in a senior QA leadership role in a regulated environment.

Hands-on experience in facing global regulatory inspections (e.g., USFDA, MHRA, ANVISA, TGA).

Sound knowledge of GMP, ICH, WHO, and other international quality guidelines.

Skills & Attributes:

Strong leadership and decision-making ability.

Excellent communication, interpersonal, and presentation skills.

High attention to detail and ability to handle complex quality issues.

Analytical mindset with risk-based thinking.