L 3 - Quality Assurance

SAVA HEALTHCARE LIMITED; Indore District; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

SAVA HEALTHCARE LIMITED in Indore is seeking a General Manager – Quality Assurance to lead all QA functions at the manufacturing site. You will ensure compliance with cGMP, regulatory guidelines, and quality standards while driving a robust QMS and a culture of compliance.

The role requires senior leadership, strategic QA oversight, batch release authority, and effective cross-functional collaboration with Production, Regulatory Affairs, and R&D.

Qualifications

• 15–20 years in the pharmaceutical industry with at least 5 years in a senior QA leadership role in a regulated environment.
• Hands-on experience facing global regulatory inspections (USFDA, MHRA, ANVISA, TGA).
• Strong knowledge of GMP, ICH, WHO and other international quality guidelines.

Responsibilities

• Lead QA department to ensure strict adherence to cGMP.
• Define and implement site-wide QA strategies and robust QMS.
• Review and approve batch records; authorize batch release per requirements.
• Oversee document control, CAPA, deviation handling and risk assessments.
• Collaborate with Production, QC, Engineering, Regulatory Affairs and R&D.

Skills

Leadership

Decision making

Communication

Interpersonal

Presentation skills

Attention to detail

Risk-based thinking

Analytical mindset

Education

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

Job description

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.

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.