Deputy / General Manager - Quality Assurance

SAVA Group; Indore District; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

SAVA Group in Indore is seeking a Deputy / General Manager – Quality Assurance to lead QA at our pharmaceutical manufacturing site, ensuring cGMP compliance, regulatory readiness, and a robust QMS.

The role emphasizes strategic QA leadership, batch release oversight, CAPA, deviation handling, and cross-functional collaboration with Production, Regulatory Affairs, and R&D.

Qualifications

• M. Pharm / B. Pharm / M.Sc. in Chemistry, Microbiology, or related life sciences field.
• Extensive experience with GMP/ICH/WHO guidelines in a regulated pharma environment.
• Leadership experience in QA leadership roles with global regulatory inspections.

Responsibilities

• Lead QA department to ensure strict adherance to cGMP and regulatory requirements.
• Define and implement site-wide QA strategies aligned with global policies.
• Oversee QMS elements: deviation, change control, CAPA, OOS, and document control.
• Review and approve batch manufacturing/packing records and authorize batch release.
• Collaborate with Production, QC, Engineering, Regulatory, and R&D for tech transfers and validations.
• Develop and mentor QA team, promoting a quality-driven culture.

Skills

Leadership

Regulatory liaison

Quality Assurance

cGMP

CAPA

QMS

Audit readiness

Documentation control

Team management

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

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.