PurposeNew Position.
Position / Job TitleManager (Supervisor / Section In-Charge).
DepartmentQuality Control
Reporting ToAGM (M1) / Site QC-Head
LocationSatara
Years of Experience11 to 15 years.
Dosage FormSolid Oral / Nasal / Liquid
Job 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. LabAutomation) 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.
