Job Description About the Company
n 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.
n 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.
n 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.
n 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.
n About the Role
n Lead and manage all Site Quality functions including Quality Assurance (QA), Quality Control (QC), Validation, Compliance, Documentation, Microbiology (if applicable), and Stability Studies.
n Responsibilities
n n Develop and implement site quality strategy aligned with business objectives and global regulatory expectations.
n Drive a culture of quality, compliance, continuous improvement, and data integrity across the organization.
n Act as the Quality Management Representative for the site.
n Ensure effective implementation and maintenance of Quality Management Systems (QMS).
n Review and approve quality policies, SOPs, specifications,



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




n Ensure compliance with 21 CFR Part 11 and global regulatory expectations.
n Drive periodic reviews and effectiveness checks of quality systems.
n Lead, mentor and develop the Quality organization.
n Build succession planning and talent development initiatives within the department.
n Foster cross-functional collaboration with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and Technical Services.
n Drive operational excellence and quality improvement projects.
n Utilize quality metrics and trend analysis for proactive risk management.
n Promote Lean, Six Sigma, and continuous improvement initiatives.
n n Qualifications
n n M.Pharm / B.Pharm / M.Sc. (Chemistry, Pharmaceutical Chemistry, Microbiology or related discipline)
n Additional qualifications in Quality Management, Regulatory Affairs, Six Sigma, or Operational Excellence will be preferred.
n n Required Skills
n n 18–25 years of experience in pharmaceutical manufacturing quality functions.
n Minimum 8–10 years in senior leadership roles heading Quality operations.
n Proven experience in managing Quality functions at a USFDA-approved formulation manufacturing facility.
n Strong exposure to Oral Solid Dosage (OSD) manufacturing including Tablets, Capsules and Powder formulations.
n n Preferred Skills
n n Hands-on experience in handling inspections and audits from: USFDA, MHRA, EU Authorities, WHO-GMP, TGA Health Canada (preferred), Customer Audits from regulated markets.
n n Pay range and compensation package
n Not specified.
n Equal Opportunity Statement
n We are committed to diversity and inclusivity in our hiring practices.

📌 Quality Lead (Bharuch)
🏢 Ajanta Pharma
📍 Bharuch