Executive

Rubicon Research Limited; Maharashtra; On-site; INR 500,000 - 800,000; Full time

Job summary

Rubicon Research Limited is looking for an Executive (Reviewer) for the Quality Control department based in Ambernath, Maharashtra. This position involves preparation and review of specifications, SOPs, and analytical reports, ensuring compliance with GLP standards, and coordinating with external laboratories. Candidates should have a Bachelor or Master Degree in Science/Pharma, along with 6 to 10 years of relevant experience, specifically in analytical review with a solid understanding of chemical analysis methods. Familiarity with Chromeleon 7.2 software is a plus.

Qualifications

• 6 to 10 years of experience in Quality Control.
• Experience handling GLP activities and incidences.
• Ability to achieve deliverables with minimum supervision.

Responsibilities

• Prepare and review Specifications, SOPs, and analytical reports.
• Coordinate with external testing laboratory for timely material release.
• Ensure availability of necessary resources for the function.

Skills

Analytical data review

Chemical analysis knowledge

Instrumental analysis (HPLC/GC/UV/IC/IR/KF/Dissolution)

Good written and communication skills

Knowledge of Chromeleon 7.2 software

Education

Bachelor / Master Degree in Science / Pharma

Job description

Overview

Executive (Reviewer) – Quality Control role based in Ambernath. Role focuses on preparation and review of Specification, SOPs, Protocols, Reports, summary sheets, water samples reports, and review of analytical raw data of LNB/AWR for compliance, correctness, and completeness.

Responsibilities / Deliverables

• Preparation and review of Specification, SOPs, Protocols, Reports, summary sheets, water samples reports, etc.; review analytical raw data of LNB/AWR for compliance, correctness, and completeness.
• Handle and ensure completion of incidences, OOS, Change Control, Deviations, etc.
• Coordinate with external testing laboratory for release of material within the time frame assigned.
• Ensure resources (chemicals/reagents/analytical columns/standards/instruments/equipment) are available to smooth line function whenever required.
• Perform tasks assigned by the supervisor/HOD as required.
• Adhere to GLP and Health, Safety and Environment systems in the laboratory.
• Demonstrate good written and communication skills.

Position Details

• Position / Job Title: Executive (Reviewer)
• Department: Quality Control
• Reporting To: Assistant Manager (P3) / Manager (P4)
• Location: Ambernath
• Years of Experience: 6 to 10 years
• Dosage Form: Solid Oral / Nasal / Liquid

Qualifications & Pre-Requisites

• Bachelor / Master Degree in Science / Pharma
• Experience in analytical data review with knowledge of chemical analysis and instrumental analysis (HPLC/GC/UV/IC/IR/KF/Dissolution)
• Experience handling and ensuring completion of incidences, OOS, Change Control, Deviations; responsible for GLP activities
• Experience in US-FDA/MHRA approved company is preferable
• Knowledge of Chromeleon 7.2 software is an added advantage
• Ability to achieve deliverables with minimum supervision

Additional Notes

Role is expected to work in all shifts. If required, 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 requirements.