Senior Manager QMS

About the job

Job Description Managing overall activity of QMS. Establishing and implementing quality systems to comply cGMP. Handling of Product Complaint, Recall, Deviation, OOS (Out of Specification), OOT (Out of Trend), Incident and Change Control. • CAPA Tracking: CAPA management, tracking, verification of implemented CAPA from CCN, Deviation, OOS, Self-Inspection and Market complaint and its final close out. • SOP: Review of SOPs, and effective implementation of SOP. • Self-Inspection: Ensure site compliance status through Internal Quality Audit (IQA) to ensure that all timemanufacturing facility is ready for external inspection. • Handling of Market Complaint: Complaint Investigation, root cause analysis, Impact assessment and risk assessment of received market complaint, FAR and Quality Defect reporting to Regulatory agency, trending of complaint and excellence study of complaint nature. • Recall and Product Failure Investigation: Product failure investigation, Periodic inspection of retained, controlled and stability sample, handle the mock recall and product recall. • Develops and executes risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups. • Participate in and respond to the inspections by regulatory authorities including MHRA, USFDA etc. representing the QMS function. • To maintain the system for regulatory compliance. • Issuance, Distribution and Retrieval of Document to respective users • Train team members in procedures relating to QA activity as required.

Qualifications

• B. Pharm
• M. Pharm
• M. Sc.

About the company

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.