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.
Positive 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.
Good understanding of deviation, CAPA, change control and risk assessment.
Valuable coordination skills with QC, Production, Engineering and external agencies.
Robust attention to detail, documentation skills and ability to meet timelines.
Candidates with hands-on experience in regulated Pharma/Cosmetic manufacturing plants will be preferred.

📌 Executive Qa Bavla (India)
🏢 Umendra Life Sciences
📍 India