Role & responsibilities
- Coordinate and execute Equipment Qualification activities, including preparation/review of qualification protocols and reports.
- Manage Cleaning Validation activities, including protocol execution, sampling, documentation and report preparation/review.
- Coordinate Calibration of instruments and equipment as per approved schedules and procedures.
- Maintain and monitor calibration records, certificates and due dates to ensure timely calibration.
- Manage Stability Study activities, including sample planning, storage condition monitoring, withdrawal schedules and documentation.
- Maintain Stability Data and Reports in compliance with approved protocols and applicable GMP requirements.
- Manage Control Samples, including receipt, identification, storage, reconciliation and destruction/retention as per SOP.
- Ensure proper documentation, data integrity and traceability for qualification, validation, calibration, stability and control sample activities.
- Coordinate with Production, QC, Engineering and external agencies for timely completion of QA activities.




- Ensure compliance with GMP/cGMP, SOPs, protocols and regulatory requirements.
- Support preparation for internal, customer and regulatory audits and ensure timely closure of observations.

Preferred candidate profile
- B.Pharm / M.Pharm / B.Sc / M.Sc with 35 years of relevant experience in Quality Assurance.
- Experience in Pharmaceutical / Cosmetic / Personal Care manufacturing preferred.
- Hands-on experience in Equipment Qualification, Cleaning Validation, Calibration, Stability Studies and Control Sample management.
- Valuable knowledge of GMP/cGMP, SOPs, GDP and Quality Management Systems (QMS).
- Experience in preparation, execution and review of qualification/validation protocols and reports.
- Knowledge of IQ/OQ/PQ, cleaning validation protocols, calibration schedules and stability study requirements.
- Ability to maintain accurate QA documentation, records and data integrity.
- Goo

📌 Executive - QA (Bavla)
🏢 Umendra Life Sciences
📍 Bavla