By admin 
RGENT HIRING for “Senior Manager (QA-QMS)| INJECTABLES 🚨
Amneal Pharmaceuticals is looking for experienced professionals to join our Quality Assurance Department at Palli, Sachana (Kadi).
🔹 Experience:14 Years-20 Years
🔹 Qualification: M.Sc / B.Pharm / M.Pharm
🔹 Department: Quality Assurance-QMS (Injectables)
📍 Job Location: Palli Sachana/Injectbale Unit
🔍 Role Highlights:
Lead overall Quality Management System (QMS) operations for sterile injectable facility.
Ensure compliance with cGMP, Data Integrity, USFDA, EU GMP, MHRA, WHO, and PIC/S guidelines.
Manage and approve:
Deviations
CAPA
Change Controls
OOS/OOT investigations
Market Complaints
Risk Assessments
Lead regulatory inspections, customer audits, and remediation activities.
Drive audit readiness and quality compliance culture across the site.
Review and approve APR/PQR, validation documents, SOPs, protocols, and investigation reports.
Oversee aseptic practices, contamination control strategy, and sterility assurance programs.
Monitor QMS metrics, trend analysis, and continuous improvement initiatives.
Lead cross-functional quality meetings and quality governance programs.
Mentor and develop QA QMS teams to improve performance and compliance.
Support digital/electronic QMS implementation and process optimization.
Coordinate with Production, QC, Engineering, Warehouse, and Regulatory Affairs departments.
Ensure timely closure and effectiveness verification of CAPA and investigations.
Handle critical quality risk assessments using tools like FMEA, Fishbone, and 5 Why analysis.
Maintain inspection readiness for global regulatory agencies and client audits.
✅ Must Have Skills/ Exposure:
✔ Experience in USFDA-approved injectable facility
✔ Strong GMP & Regulatory Compliance knowledge
✔ Excellent communication & audit exposure
📩 Interested? Apply Now!
Share your CV with subject: “Application for Quality Assurance(QMS Lead).
SWARNALATHA B