Assistant Manager

Position / Job TitleAssistant Manager (Supervisor / Section In-Charge).DepartmentQuality Control Reporting ToSr. Manager (P4) / AGM (M1)LocationAmbernath Years of Experience11 to 15 years.Dosage FormSolid Oral / Nasal / Liquid Job Responsibilities / Deliverables

• Responsible for leading the team of approx. 10+ 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 limitas 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.