Executive - Technology Transfer

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.

Skills Required

Qa, Sap, Qc, Production, bmr writing, Scm, Mfc