Position / Job Title

Executive / Sr. Executive (Reviewer).

Department

Analytical Method Validation

Reporting To

Assistant Manager / Manager

Location

Indore

Years Of Experience

6 to 10 years

Dosage Form

Solid Oral / Nasal / Liquid.

Job Responsibilities / Deliverables

Responsible to daily work planning & allocation analytical work of method validation / method verification / method transfer for API and finished products.

Preparation and review of SOPs, Protocols, Reports, Summary sheets etc. to review analytical raw data of LNB / Reports for compliance, correctness, and completeness.

To coordinate with 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.) available to smooth line function whenever required.

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

If required need to provide support for QC 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, 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 Empower software (Waters HPLC) 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.

Senior Executive