Senior Executive - QA

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.
• Strong 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.
• Good understanding of SOPs, BMR/BPR, audit compliance and data integrity.
• Strong 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.