Job Description:

Job Responsibilities / Deliverables
- Responsible for leading the team of Approx 10+ members (QMS Reviewer) for respective section and planning and monitoring daily QMS activities to ensure timely completion and Closers.
- He is responsible for QMS activities, including incident handling, investigations, file notes, ratifications, Out of Specification (OOS), Out of Trend (OOT), Change Controls, Deviations and Corrective and Preventive Actions (CAPA).
- Ensured timely closure of all QMS records within stipulated timelines by conducting thorough root cause analysis and implementing effective corrective and preventive actions.
- Coordinate with cross-functional teams for investigations with R&D;, Quality Assurance, Production, Engineering, Warehouse, Validation, and Regulatory Affairs to resolve complex quality events.
- He is responsible to Perform comprehensive root cause investigations using structured problem-solving tools like 5 Why Analysis, Fishbone (Ishikawa) Diagram, Fault Tree Analysis, and Risk-Based Assessment to identify the true cause of quality issues.




- Responsible for arranging a review of analytical raw data for correctness and completeness and to ensure final data submission to QA or other respective departments as per specified timelines.
- To ensure and arrange all resources available to smooth line functions as per planning and achieve deliverable task with minimum support.
- He is responsible for facing the Audit (USFDA/MHRA/Client etc.) with respective section related work. Should ensure completion, compliant and inspection-ready QMS documentation.
- Should have positive written and communication skills and perform the task given by the Sr. Leader as and when required.
- Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.

Qualifications & Pre-Requisites

Preferably have following skill but not limitas mentioned below;
- Bachelor / Master Degree of Science / Pharma.
- He should have good experience

📌 Senior Manager (Ambernath)
🏢 Rubicon Research
📍 Ambernath