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. Authorization / perform to operate and qualifications of Incubator shakers, Biosafety cabinet, Horizontal autoclaves. Perform media preparation, media sterilization for inoculum preparation stage. Perform aseptic operation for vial inoculation, sub culturing and pooling activities inside clean room. Generate inoculum for cell bank qualification. To generate seed inoculum as per Production requirement. Coordinate with the R&D / QC micro related to process development. Entering data in quality records (i.e Usage e-log/logbooks, cleaning e-log/log books, Calibration log books and ESP's etc...) Initiation, Review, coordinating CFT, providing supporting documents and responsible for closure of all QMS related documents (Change control, deviation, OOS, OOT, CAPA, audit management, Etc.,) in applicable software like Track wise. Responsible for dispensing / Verification of Raw Material and storage / in process activities. Coordinate with QA for all the validation, qualification and Audit preparedness./ Handling of Regulatory, customer, CQA Audits, preparation of response & its closure. 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. Preparation & 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. Operate the Fermenters, NDV's, MPV's, CIP tanks, etc... Through MES / SCDA system. Responsible for cleaning and verification of the equipment/accessories as per equipment cleaning checklist / approved procedures. Responsible for all the manufacturing operations as per respective EBMR/Checklist routine monitoring and recording of documents as per approved procedures. Responsible for Production Planning, personnel scheduling, raw material planning with senior members of production. Receiving of the raw materials from the Stores through the Material Requisition Slip. 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. Authorized for imparting training in QMS documents to own departmental employees and other department employees. Handling of hazardous / Non-hazardous & solid / liquid waste material. Education & Experience Qualification: MSc (Biotechnology) Experience: 12 to 15 years
Job Title
Lead - Inoculum Preparation Lab