Senior Executive, QMS
AhmedabadFull-time5–8 yrsPosted 1 week ago
Senior mechanical and production role at Hcfa in Ahmedabad. Needs 5–8 years and a B.Pharm or M.Pharm.
About the role
Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance. Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines.
What you'll do
- Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA)
- Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership
- Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures
- Support internal audits, customer audits, and regulatory inspections
- Assist in the development, review, and revision of SOPs and other quality system documents
What you need
- ISO 9001
- GMP
- Root cause analysis
- Quality control
- Internal audit
- SOP writing
Good to have
- GLP
- Medication administration