Job
Description
Role & responsibilities: To receive instructions from AM / Manager / GM. To plan the work as per instructions from department head. To track the daily exhibit / site shift product's trail, engineering, Exhibit & Validation (not limited to) batches manufacturing and monitor it's progress constantly. To organize, supervise and control the activities of Technology Transfer department. To co-ordinate and co-operate with various departments like Raw material store, Engineering, Quality Assurance, Administration, Information Technology, Operational Project, Quality Control, Production etc. for smooth functioning of Technology Transfer department. To check and update various documents and records, ensure production records filled online during batch manufacturing. To check and maintain housekeeping of the department. To enforce latest developments in GMP, SOP's etc. To observe and report to the seniors of Product / Material / Machine for their abnormal identified behaviour during production process. To counter check Raw Materials Dispensing and to recheck the material prior to their use in production processes. To ensure that the Quality, Health, Safety, Environment policy and procedures are followed. To prepare documents of New Product (ANDA) and site shift products (which includes CCF, MFC, BMR, QFR, ISP, PPQP, QRM, ESR TT Protocol, TT Report & PPQR (not limited to). To prepare documents for MES activity. To check, (i) Sampling request to Quality Assurance Department (ii) Material requirements requisitions (iii) Received batch from RM department To check / verify, (i) Daily Work in progress status. To achieve required production targets as per the budgetary norms. Handling of change parts. To ensure proper follow of company's rules and regulations. To ensure that all documents are complete in all respect prior to next stage of processing. To write requisition slips of Auxiliary Materials / Stationary materials etc. of daily use. To procure and control the utilization of such materials. To maintain optimum stock level of such materials for smooth functioning of department. To carry out any additional responsibility entrusted from time to time. Monitoring of Production process at each stage. To understand and follow all written procedure and manufacturing instructions mentioned in the respective batch record or any other quality document before starting production activity. To monitor constantly the CAPA of deviations, OOT and OOS to complete within time frame. To perform the investigation within timeframe related to quality system i.e. deviation, OOT and OOS. To be in communication with TRC and it's cross functional team for coordination and knowledge sharing of new site transfer products. To ensure that all SOP trainings are fulfilled on periodic basis. To coordinate activities like visit, document transfer and monitoring (but not limited to) related to manufacturing of products at CMO site. Preferred candidate profile: Candidates should have experience in Pharmaceutical background. Qualification: M. PHARM. Experience: 3 to 8 Years
