QA Manager

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