Department Details

Role Summary

A Senior Executive-level position is proposed to support the ongoing and expanding operational requirements of the Fermentation Production Department, with specific focus on the Inoculum Preparation and Generation Laboratory. This role is critical to ensuring uninterrupted continuity of aseptic and contamination controlled activities across multiple products and multiple microbial organisms, which are central to biologics and fermentation based manufacturing operations.
The incumbent will be responsible for executing assigned functions in strict compliance with regulatory guidelines, quality systems, and safety standards, thereby ensuring consistent and reliable production outcomes. Key responsibilities include hands on involvement in inoculum preparation and generation, execution of defined processes, and end to end handling of laboratory equipment and instruments. The role also encompasses comprehensive management of both electronic and physical documentation, as well as effective coordination with multiple cross functional departments, including Production, Quality Control (QC), Quality Control Microbiology (QCM), Quality Assurance (QA), Engineering, Instrumentation, Warehouse (WH), Effluent Treatment Plant (ETP), and Safety teams.
The ideal candidate will possess strong hands on experience in inoculum preparation and generation, preferably within biologics and fermentation API manufacturing environments. Practical exposure is required in supplying inoculum to biologics and fermentation production processes, along with operational expertise in a wide range of inoculum laboratory equipment. This includes, but is not limited to, horizontal autoclaves, biosafety cabinets (BSC), incubator shakers, ultra low temperature freezers, BOD incubators, biochemical analysis instruments, and associated utilities.
Additionally, the role demands working knowledge of automation and digital systems such as SCADA and DCS, preparation and review of operational and analytical reports, execution of ValGenesis activities, and handling of SAP transactions. Responsibilities also extend to equipment qualification, calibration oversight, cleanroom and classified area maintenance, HVAC system monitoring, fumigation activities, and adherence to stringent aseptic practices.
Exposure to QC Microbiology activities and demonstrated experience working within cGMP, GDP, and GLP compliant environments are essential. The position also requires robust understanding and execution of biologics related documentation, including SOPs, batch records, validation protocols, deviation handling, change controls, and CAPAs.
The selected candidate will actively participate in and support regulatory inspections and audits, including customer, CQA, and vendor audits, and will manage quality events through QMS platforms such as TrackWise. An important component of the role is the training, mentoring, and supervision of subordinate staff, ensuring knowledge transfer, skill development, and sustained operational excellence within the team.
This experience and skill set are essential to maintaining process efficiency, ensuring regulatory and quality compliance, and supporting the department's objectives of delivering consistent, high quality biologics and fermentation outputs.
The requisition for this position has been raised to effectively manage current workload pressures, support upcoming projects, and bridge existing skill gaps, particularly those associated with biologics focused and aseptic inoculum operations, thereby strengthening the department's overall operational capability.

Key Responsibilities
• Adherence to Standard Operating Procedures, GMP.
• Performing necessary calibration / verification (pH meter and weighing balance) and recording of documents as per approved procedures maintaining equipment surface area in cleaned condition.
• Authentication / perform to operate Incubator shakers, Biosafety cabinet, Horizontal autoclave.
• To perform media preparation, media sterilization for inoculum preparation stage.
• To perform aseptic operation for vial inoculation, sub culturing and pooling activities inside clean room.
• To generate inoculum for cell bank qualification.
• To generate seed inoculum as per production requirement.
• To coordinate with the RND / QC micro related to process development.
• Entering data in quality records (i.e., Usage logbooks, Cleaning logbooks, Calibration logbooks and etc).
• Initiation, Review, coordinating CFT and providing supporting documents for all QMS related documents (Change control, deviation, OOS, OOT, CAPA, audit management, Etc.,) in applicable software like Trackwise.
• Responsible for dispensing / Verification of Raw Material and storage / in process activities.
• To coordinate with QA for all the validation, qualification and Audit preparedness.
• Reporting of non-conformities and adherence and initiation to the corrective / preventive actions with quality assurance, senior members of production department and other concerned departments in specific areas of operation.
• Imparting training on SOP's, EOP's, IOP's, BMR, ECC and Process related aspects to maintain quality and consistency in Production.
• Monitoring of process efficiency, equipment / accessories cleaning and Housekeeping.
• Adhering to EHS policy and safety Guidelines.
• Adherence to the company for Zero tolerance policy and Code of conduct policy.
• To follow the established procedures and policies of the company pertaining to EHS management system, operation and maintenance of fire hydrant system, fire alarm system, emergency safety cupboard, fire extinguishers and equipment shutdown procedure
• Handling of work permit system.
• Authorized for imparting training in QMS documents to own departmental employees and other department employees.
• To follow the established procedures and policies of the company pertaining to EHS management system.
• Handling of hazardous / Non-hazardous & solid / liquid waste material

Educational Qualifications

Required Education Qualification: M.Sc
Required Experience: 4 - 8 years