Senior Manager

Rubicon Research Limited; Thane; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Rubicon Research Limited in Maharashtra's Thane region invites an experienced QMS Reviewer to lead a 10+ member team responsible for monitoring daily QMS activities, closers, and timely documentation.

The role encompasses incident handling, investigations, CAPA, deviations, change controls, and audits (USFDA/MHRA/clients). Strong root-cause analysis, data review, and GLP/GMP compliance are essential.

Qualifications

• Bachelor/Master degree in Science/Pharma and team handling experience.
• Experience with modern analytical instruments and data review.
• Knowledge of GLP-GMP standards and QMS handling.
• Preference for US-FDA/MHRA experience.

Responsibilities

• Lead a 10+ member QMS Reviewer team and monitor daily QMS activities.
• Handle QMS activities: incidents, investigations, file notes, OOS/OOT, CAPA, and deviations.
• Ensure timely closure of QMS records with root cause analysis and corrective actions.
• Coordinate cross-functionally with R&D, QA, Production, Engineering, Validation, and Regulatory Affairs.
• Perform root cause investigations using 5 Why, Ishikawa, Fault Tree, and risk-based methods.
• Review analytical raw data for accuracy and ensure timely submission to QA.
• Arrange resources to smooth line functions and meet deliverables.
• Prepare for audits (USFDA/MHRA/Client) with compliant, inspection-ready QMS documentation.
• Demonstrate strong written and verbal communication; support Sr. Leader as needed.
• Ensure GLP and Health, Safety, and Environment compliance in the lab.

Skills

Team leadership

QMS management

Incident handling

Investigations

CAPA

Root cause analysis

Risk assessment

Data review

Audit readiness

GLP/GMP compliance

Education

Bachelor/Master in Science/Pharma

Tools

Chromleon 7.2

Job description

• 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.

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.