Sr. Executive (Reviewer) - GLP

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

Job summary

Rubicon Research in Ambernath is seeking a Sr. Executive (Reviewer) for the Quality Control department. The role involves reviewing specifications, SOPs, protocols and reports, and ensuring data integrity across LNB/AWR analyses.

The candidate should have 8–12 years of experience in analytical data review, GLP compliance, and proficiency with analytical instruments such as HPLC/GC/UV/ IC/IR/KF/Dissolution. Willingness to work shifts and travel to plant locations is expected.

Qualifications

• Bachelor/Master in Science or Pharma.
• Experience in analytical data review and chemical analysis.
• Experience with OOS, Change Control and Deviations; GLP experience.
• US-FDA/MHRA exposure preferable; Chromeleon 7.2 knowledge is an advantage.

Responsibilities

• Prepare and review specifications, SOPs, protocols, reports and water samples reports.
• Review analytical raw data for compliance and accuracy.
• Handle incidences, OOS, Change Control and Deviations; ensure completion.
• Coordinate with external testing labs for timely release of material.
• Ensure availability of chemicals, reagents, instruments and other resources.
• Perform tasks assigned by supervisor/HOD; adhere to GLP and HSE in lab.
• Demonstrate good written and communication skills.

Skills

Analytical data review

GLP compliance

Written and verbal communication

Coordination with labs

Education

Bachelor/Master in Science/Pharma

Tools

Chromeleon 7.2

Job description

Position /Job Title -

Sr. Executive (Reviewer).

Department -

Quality Control

Location -

Ambernath

Years of Experience -

8 to 12 years

Dosage Form -

Solid Oral / Nasal / Liquid.

Job Responsibilities / Deliverables

• Preparation and review of Specification, SOPs, Protocols, Reports, summary sheets, water samples report etc. To review analytical raw data of LNB / AWR for compliance, correctness, and completeness.
• To handle and ensure completion of all incidences, OOS, Change Control, Deviations etc.
• To coordinate with external testing laboratory for the release of material within the time frame assigned.
• To ensure resources (Chemicals / Reagents / Analytical columns / Standards / Documents / Instruments / Equipments etc.) available to smooth line function whenever required.
• To perform the task assigned by the supervisor/HOD as and when required.
• Responsible to adherence of GLP and Health, Safety Environment system in Laboratory.
• Should have good written and communication skill.

Qualifications & Pre-Requisites

Preferably have following skill but not limited as mentioned below;

• Bachelor / Master Degree of Science / Pharma.
• He should have good experience of analytical data review and good knowledge of Chemical analysis, instrumental analysis like HPLC/GC/UV/ IC/IR/KF/Dissolution.
• He should have experience of Handling and ensuring completion of all incidences, OOS, Change Control, Deviations etc. Responsible for ensuring completion of GLP activities.
• The candidate having experience in US-FDA/MHRA approved company is preferable.
• Knowledge of Chromeleon 7.2 software will be an added advantage.
• Should have skill to achieve deliverable task with minimum support for analysis.

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.