About the Company Ajanta Pharma is a specialty pharmaceutical company committed to developing, manufacturing, and marketing high-quality, affordable medicines. Headquartered in Mumbai, India, the company has a strong presence across India and international markets, with operations spanning Asia, Africa, the Middle East, CIS, and the United States. The company focuses on delivering innovative healthcare solutions across multiple therapeutic segments, supported by state-of-the-art manufacturing facilities, advanced R&D; capabilities, and a strong commitment to quality and regulatory compliance.

At Ajanta

Pharma, our people are our greatest strength. We foster a culture of innovation, integrity, collaboration, and continuous learning, providing employees with opportunities to grow, take ownership, and build rewarding careers while making a meaningful impact on global healthcare.

Join Ajanta

Pharma and be a part of an organization that is dedicated to improving patients' lives through quality medicines and excellence in everything we do.

About the Role Lead and manage all Site Quality functions including Quality Assurance (QA), Quality Control (QC), Validation, Compliance, Documentation, Microbiology (if applicable), and Stability Studies.

Responsibilities - Develop and implement site quality strategy aligned with business objectives and global regulatory expectations.

- Drive a culture of quality, compliance, continuous improvement, and data integrity across the organization.
- Act as the Quality Management Representative for the site.
- Ensure effective implementation and maintenance of Quality Management Systems (QMS).
- Review and approve quality policies, SOPs, specifications, protocols,



reports, and master documents.
- Ensure effective management of deviations, OOS, OOT, CAPA, change controls, risk assessments, complaints, recalls, and annual product quality reviews.
- Monitor and improve quality metrics and compliance indicators.
- Ensure robust analytical testing and release systems for raw materials, packing materials, in-process samples, finished products, stability samples, and water systems.
- Oversee laboratory compliance, method validation, method transfer, calibration, and qualification activities.
- Ensure compliance with ALCOA+ principles and data integrity requirements.
- Ensure continuous compliance with USFDA, MHRA, EU GMP, WHO-GMP, PIC/S, and other applicable regulatory requirements.
- Lead site readiness and management of regulatory inspections and customer audits.
- Act as primary quality representative during regulatory inspections.
- Ensure timely closure of audit observations and implementation of sustainable CAPAs.
- Oversee qualification and validation programs including: Equipment Qualification, Process Validation, Cleaning Validation, Computer System Validation, Utility Qualification, Analytical Method Validation.
- Establish and maintain a strong Data Integrity framework across manufacturing and laboratory operations.




- Ensure compliance with 21 CFR Part 11 and global regulatory expectations.
- Drive periodic reviews and effectiveness checks of quality systems.
- Lead, mentor and develop the Quality organization.
- Build succession planning and talent development initiatives within the department.
- Foster cross-functional collaboration with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and Technical Services.
- Drive operational excellence and quality improvement projects.
- Utilize quality metrics and trend analysis for proactive risk management.
- Promote Lean, Six Sigma, and continuous improvement initiatives.

Qualifications - M.Pharm / B.Pharm / M.Sc. (Chemistry, Pharmaceutical Chemistry, Microbiology or related discipline)

- Additional qualifications in Quality Management, Regulatory Affairs, Six Sigma, or Operational Excellence will be preferred.

Required Skills - 18–25 years of experience in pharmaceutical manufacturing quality functions.

- Minimum 8–10 years in senior leadership roles heading Quality operations.
- Proven experience in managing Quality functions at a USFDA-approved formulation manufacturing facility.
- Solid exposure to Oral Solid Dosage (OSD) manufacturing including Tablets, Capsules and Powder formulations.

Preferred Skills - Hands-on experience in handling inspections and audits from: USFDA, MHRA, EU Authorities, WHO-GMP, TGA Health Canada (preferred), Customer Audits from regulated markets.

Pay range and compensation package Not specified.

Equal Opportunity Statement We are committed to diversity and inclusivity in our hiring practices.

📌 Quality Lead (Amleshwar)
🏢 Ajanta Pharma
📍 Amleshwar