PurposeNew Position.Position / Job TitleManager (Supervisor / Section In-Charge).DepartmentQuality ControlReporting ToAGM (M1) / Site QC-HeadLocationSataraYears of Experience11 to 15 years.Dosage FormSolid Oral / Nasal / LiquidJob Responsibilities / Deliverables

Responsible for leading the team of approx. 15+ members (Analyst + Reviewer) for the Microbiological section and releasing the batches after completion of analysis or any other given task as per target completion date.
Responsible for arranging a review of analytical raw data for correctness and completeness and to ensure final data submission to respective departments as per specified timelines.
Responsible for leading any type of automation project (E.g. Lab—Automation) in Lab and actively participate in succeeding it through ownership.
Responsible for QMS handling (incidences, investigations, File notes, ratification, OOS, OOT, Change Control, CAPA etc.) and closing within a stipulated timeline with the proper root cause of his section.
To ensure and arrange all resources (chemicals, reagents, media, standards, cultures, documents, etc.) are available to smooth line function as per planning and achieve a deliverable task with minimum support.
He should be self-driven, have the capability to make self-decisions and be a good learner. He should have the capability to lead the Microbiological section individually and actively participate in departmental improvement programs to enhance the output and quality.
To perform the task assigned by the HOD as and when required.
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 to the GLP and the EHS system in the Laboratory.

Qualifications & Pre-Requisites

Preferably have following skill but not limit as mentioned below;

Master Degree of Microbiology.
He should have good experience of analytical data review and good knowledge of MLT, Water and EM analysis, instrumental analysis like water activity / Horizontal Autoclave / Balance.
He should have experience of QMS Handling and know about GLP-GMP standard practices of analytical work.
The candidate having experience in US-FDA/MHRA approved company is preferable.
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.