Position / Job Title

Assistant Manager

Department

Analytical Method Validation

Reporting To

Sr. Manager / AGM

Location

Satara

Years Of Experience

11 to 15 years.

Dosage Form

Liquid / Solid Oral / Nasal Potent

Job Responsibilities / Deliverables

Responsible for leading the team of Approx 10+ members (Analyst + Reviewer) for respective section and release the batches after completion of method validation / method verification / method transfer for API, finished products and any other given task as per target completion date.

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.

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

Should acquaint with new laboratory techniques like Raman/ FTNIR / UPLC etc.

He is responsible for QMS handling (Incidences, Investigations and File notes, Ratification, OOS, OOT, Change Control and CAPA etc.) and closing within stipulated timeline with proper root cause of his section.

To ensure and arrange all resources available to smooth line function 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 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 limit as 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.