Senior Manager

rubicon research limited

Fresher

Ulhasnagar, India

Posted 9 hours ago

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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 good 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 of team handing (Analyst + Reviewer) for respective section. He should have past analytical experience of modern instruments like HPLC, GC, IR, UV, IC, KF, Dissolution etc. and requires knowledge of data review.
He should have experience of QMS Handling and know about GLP-GMP standard of analytical work.
The candidate having experience in US-FDA/MHRA approved company is preferable.
Knowledge of Chromleon 7.2 software will be an added advantage.

Additional Notes

Role is expected to work in all shifts.
If required, the candidate should be ready to travel to all plant locations on work priority as per company policy.
Responsible to ensure compliance to GLP, Health, Safety and Environment. requirement.