Quality Lead

About Ajanta Pharma Ltd

Ajanta Pharma is a specialized pharmaceutical company dedicated to the creation, production, and distribution of high-quality, cost-effective medications. Based in Mumbai, the company operates extensively across India and global markets including Asia, Africa, the Middle East, CIS, and the USA. The firm emphasizes innovative healthcare across multiple therapeutic areas, leveraging advanced manufacturing technology, superior research and development, and a strong focus on quality and regulatory adherence. The organization values its workforce, promoting a culture of innovation, integrity, teamwork, and lifelong learning, offering career development opportunities that create impactful contributions to global health outcomes.

Position Overview

The Quality Lead will oversee the entire Site Quality functions such as Quality Assurance, Quality Control, Validation, Compliance, Documentation, Microbiology (where applicable), and Stability Studies. The role demands strategic leadership and operational excellence to ensure quality standards meet business goals and comply with global regulations.

Key Responsibilities

• Design and execute the site quality strategy aligned with corporate objectives and regulatory frameworks.
• Champion a culture centered on quality, compliance, continuous enhancement, and data integrity across all departments.
• Serve as the official Quality Management Representative for the facility.
• Ensure the establishment and upkeep of an efficient Quality Management System (QMS).
• Review and authorize quality documents including SOPs, policies, specifications, test protocols, and master documentation.
• Manage deviations, out-of-specification (OOS) and out-of-trend (OOT) results, corrective and preventive actions (CAPA), change controls, risk assessments, customer complaints, recalls, and yearly product quality reviews effectively.
• Monitor and improve quality metrics and regulatory compliance indicators.
• Guarantee reliable analytical testing and release processes for raw materials, packaging, in-process checks, finished goods, stability samples, and water systems.
• Supervise laboratory compliance and activities related to method validation, transfer, equipment calibration, and qualification.
• Ensure adherence to ALCOA+ principles and maintain data integrity standards.
• Maintain continuous conformity with USFDA, MHRA, EU GMP, WHO-GMP, PIC/S, and other relevant regulatory requirements.
• Lead site preparation and manage all regulatory inspections and customer audits.
• Act as the principal quality contact during regulatory inspections and ensure timely resolution of audit findings and effective corrective actions.
• Oversee validation programs including Equipment Qualification, Process, Cleaning, Computer System, Utility, and Analytical Method Validations.
• Implement and uphold a robust Data Integrity framework across manufacturing and laboratory operations.
• Ensure compliance with 21 CFR Part 11 and global standards.
• Conduct periodic reviews and effectiveness audits of quality systems.
• Lead and mentor the quality department, driving succession planning and staff development.
• Encourage collaborative partnerships with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and Technical Services.
• Promote operational excellence and continuous quality improvement initiatives.
• Utilize quality data and trend analysis for proactive risk management.
• Drive Lean, Six Sigma, and other continuous improvement projects.

Required Qualifications

• Educational background with M.Pharm, B.Pharm, or M.Sc. in Chemistry, Pharmaceutical Chemistry, Microbiology, or related fields.
• Additional certifications in Quality Management, Regulatory Affairs, Six Sigma, or Operational Excellence are advantageous.

Experience

• 18 to 25 years’ experience in pharmaceutical manufacturing quality roles.
• At least 8 to 10 years in senior leadership overseeing quality operations.
• Track record managing Quality functions at USFDA-approved formulation manufacturing facilities.
• Extensive knowledge of Oral Solid Dosage manufacturing, including tablets, capsules, and powders.

Preferred Experience

• Direct audit and inspection experience with USFDA, MHRA, EU Authorities, WHO-GMP, TGA, Health Canada, and audits from regulated market customers.

Additional Information

Ajanta Pharma is an equal opportunity employer committed to diversity and inclusion in its hiring process.