Job Description

Position / Job Title - Sr. Executive (Reviewer).

Department - Analytical Method Validation

Reporting To - Manager (P4) / AMV – Section Head (M1)

Location - Pithampur

Years of Experience - 06 to 12 Years

Dosage Form - Solid Oral

Job Responsibilities / Deliverables

Responsible for work planning of method validation, method verification and method transfer activities for API and finished products.

Arrange the Direct or In-direct analytical method transfer activities at different locations of Rubicon as well as different CMOs and successfully complete it with ownership.

Actively participate in method troubleshooting with prompt resolution during method transfer or method verification activities.

Preparation and review of SOPs, Analytical raw data, Protocols, Reports, Summary sheets for compliance, correctness, and completeness.

To coordinate with the analytical development team to ensure timely availability of all pre-requisites required for validation and in case of discrepancies observed during validation / verification / transfer.

To ensure resources (Chemicals / Reagents / Analytical columns / Standards / Documents / Instruments / Equipment's etc.) are available to smooth line function whenever required.

To perform the task assigned by the supervisor/HOD as and when required.

If required, we need to provide support for QC as and when required.

Responsible for adherence to the GLP and the Health, Safety and Environment system in the Laboratory.

Candidate should have good writing and communication skills.

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, initiation, execution & approval of all incidences, investigations, file notes, ratification, OOS, OOT, Change Control, Deviations and CAPA 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 and Empower 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 or CMO on work priority as per company policy.

Responsible to ensure compliance to GLP, Health, Safety and Environment requirement.

Senior Executive