Role & responsibilities
Handle day-to-day AQA/IPQA activities in manufacturing and packing areas.
Perform line clearance and verify manufacturing/packing operations.
Review BMR, BPR and other batch-related documents.
Ensure adherence to GMP, SOP, GDP and quality procedures.
Monitor manufacturing processes and identify quality/GMP deviations.
Initiate and support investigations for deviations, incidents, OOS/OOT and complaints.
Prepare, implement and monitor CAPA and Change Control.
Support process validation, cleaning validation and qualification activities.
Review QA-related SOPs, protocols, reports and records.
Participate in internal, customer and regulatory audits.
Ensure timely closure of audit observations and compliance actions.
Conduct GMP awareness and documentation training for plant personnel.
Coordinate with Production, QC, Warehouse, Engineering and other departments.
Maintain proper documentation and ensure data integrity.
Ensure continuous improvement of the Quality Management System (QMS).

Preferred candidate profile




B.Pharm / M.Pharm / B.Sc / M.Sc with 48 years of relevant experience in Quality Assurance.
Experience in Pharmaceutical, Cosmetic, Personal Care or regulated manufacturing industries preferred.
Hands-on experience in AQA/IPQA, GMP compliance, line clearance and batch documentation review.
Robust knowledge of cGMP, GDP and Quality Management Systems (QMS).
Exposure to Deviation, CAPA, Change Control, OOS/OOT, Risk Assessment and investigation.
Experience in process/cleaning validation and equipment qualification will be an added advantage.
Valuable understanding of SOPs, BMR/BPR, audit compliance and data integrity.
Robust documentation, analytical, communication and coordination skills.
Ability to work effectively with Production, QC, Warehouse and Engineering teams.
Candidates who can independently handle shop-floor QA activities and compliance requirements will be preferred.

📌 Senior Executive Qa Bavla
🏢 Umendra Life Sciences
📍 Bavla