The role would encompass a variety of responsibilities, including and not necessarily limited to the following points: Oversee and maintain comprehensive QA documentation (SMF, QMS, SOPs, PVPR, COPP, etc.) as per regulatory standards. Interpret and implement pharmacopeial requirements (IP, BP, USP, etc.) for establishing and updating procedures in the production of allopathic medicines. Lead process validation, equipment qualification, water system validation, and ensure meticulous documentation for all QA activities. Manage and resolve OOS, change control, CAPA, deviation, in-process control, and maintain the Master Formulation Record. Prepare the facility for, and confidently face, inspections by FDCA, WHO, MNC, and third-party authorities; ensure successful audit closures. Oversee and review stability studies for both existing and new products. Ensure compliance with national and international guidelines, maintaining a state of audit readiness at all times. Utilize basic computer systems for QA documentation and reporting. Lead and mentor the QA team, fostering a disciplined, compliant, and positive work environment. Demonstrate a hands-on approach, being flexible and available for extended hours as required. Key Requirements: In order to perform your role well, the following qualities will be required: B.Sc., M.Sc., B.Pharm, M.Pharm, or PhD in Pharmaceutical Sciences or related fields will be preferred. Minimum 15 years’ experience in a pharmaceutical field (tablets, capsules, dry syrup, liquid oral, external ointment), with at least 5 years as QA Manager . Profound knowledge of QA documentation as per Drugs and Cosmetics Act, New Schedule M, and WHO guidelines. Strong expertise in manufacturing process validation, equipment qualification, water system validation, OOS, change control, CAPA, deviation, in-process control, and stability studies . Ability to interpret pharmacopeial monographs and translate them into actionable procedures. Demonstrated capacity to handle regulatory inspections and ensure compliance. Excellent team handling skills , with a disciplined and compliant attitude. Strong character , adaptable, and committed to organizational goals. Age ideally between 40–50 years . Good to have skills (not mandatory): Fair knowledge of quality control testing (chemical, instrumental, microbiological methods). Understanding of calibration of testing equipment. Familiarity with allopathic medicine QC documentation as per regulatory standards. Good written and spoken English for effective communication and audit preparedness. Willingness to reside on the factory campus. Knowledge of documentation for MHRA, PIC/S, etc. Ideal Candidate Profile: A disciplined, positive, and flexible leader who prioritizes work, maintains high compliance standards, and motivates the team with a cheerful and adaptable approach. The ideal candidate is proactive, solution-oriented, and ready to work extended hours to support the company’s growth and regulatory excellence. Job Types: Full-time, Fresher Pay: ₹400,000.00 - ₹1,200,000.00 per year Work Location: In person Speak with the employer +91 9218051529