Job Description

Job Role : Executive - Manufacturing Science and Technology GroupEssential function of theJob : \xc2\xb7 Timely and successfully execution of Placebo, Feasibility, Process development, Registration, Pilot Bio, Exhibit and PPQ Batches. \xc2\xb7 Documentation for Feasibility / Process Development / Registration / Pilot Bio / Exhibit batches / PPQ batches. \xc2\xb7 Procurement of change parts / RM. \xc2\xb7 Ensure compliance to cGMP / Regulatory requirement. \xc2\xb7 Resolve Filing related queries.Training Required : As per the approved training matrix for functional Responsibilities.Relationship withSuperiors : Functional Supervisors and Head of Production, QC, NPQC, QA, RA, Engineering, R&D, Planning, Global Supply Chain.Peers : Interact closely with the peers of various associated departments, Production / QA / QC / NPQC / Planning / Engineering / RBC / DRA / GMS / FRD / ARD to fulfil the requirements of the job role. Work in Co-Ordination with peers for adequate utilization of resources and working in a team.Subordinates : Assist them on technical matters that are beyond their scope of resolution. Ensure that the necessary assistance is provided to them for their timely, adequate and accurate completion of the assigned work. Training of subordinates as per need basisReporting to : Senior Research Manager (MSTG)Page No. 01 of 03Job Responsibilities : \xc2\xb7 To ensure planning and procurement of change parts, raw materials. \xc2\xb7 To ensure Co-ordination and timely execution of feasibility, process development, registration, exhibit, pilot bio- batches & PPQ batches. \xc2\xb7 To ensure SOP & cGMP compliance in Master Documentation. \xc2\xb7 To maintain review of master batch production records and SOPs. \xc2\xb7 To ensure QMS activities- Initiation and tracking of proper documentation of Deviation, OOS, Change controls and implementation of CAPA. \xc2\xb7 To ensure the quality, purity, safety, identity of drug product in accordance with MI. \xc2\xb7 To monitor and cross check the manufacturing activities and cleaning activities in different process areas. \xc2\xb7 To maintain and control the RM warehouse inventory of MSTG at Paonta sahib Location. \xc2\xb7 To maintain FO/MI\'s, Protocols, Reports, TDP and Technology transfer dossier. \xc2\xb7 To take care MDN Creation of expired raw material (Excipients & API) of PDL warehouse. \xc2\xb7 To motivate the workmen by proper training in activity and safety matter, timely guidance of subordinates so that they can achieve results successfully first time and for every time.Initiation ofDocuments : \xc2\xb7 Protocol and reports of feasibility study trial batch, process development batch, Exhibit/ PPQ batch, in-process holding time study, \xc2\xb7 FO/MI of Exhibit/ PPQ batch, MI of registration and Pilot bio batch. \xc2\xb7 Change control related Process Development Batch, Registration, Exhibit, PPQ batch, Pilot bio batch, \xc2\xb7 Initiation of Track-wise Documents [PD, UPD, Investigations, CAPA, Change Controls], \xc2\xb7 Creation/extension/deletion of RM, API & INTM code in SAP, \xc2\xb7 Initiation of reservation/PO of material in SAP for feasibility batch and process development batch. \xc2\xb7 Initiation of purchase request, \xc2\xb7 Initiation of checklist for new molecule introduction to the site and exhibit batch. \xc2\xb7 Initiation of Code to Code Transfer Requests, \xc2\xb7 Specification Linkage Requests and Self-life and retest period extension. \xc2\xb7 Initiation of analytical request for feasibility batch, process development batch, exhibit/ PPQ batch, registration batch, bio-batch. \xc2\xb7 Initiation of additional test request for investigational product, innovator product vs. in-house product and analysis of product as per requirement of data submission to regulatory agency. \xc2\xb7 Initiation of SAP related activities (Vendor locking and Recipe creation). \xc2\xb7 Other assignments, as assigned by the superior.Page No. 02 of 03Review of Documents : \xc2\xb7 Review of Protocol and reports of feasibility study trial batch, Process development batch, Registration, Exhibit and PPQ batch, in-process holding time study, \xc2\xb7 FO/MI of Exhibit / PPQ batch, MI of registration and bio batch. \xc2\xb7 Review & Approval of SOP\'s.Approval ofDocuments : \xc2\xb7 Protocols and reports of feasibility study trial batch, process development batch, exhibit / PPQ batch, in-process holding time study, cleaning validation. \xc2\xb7 FO / MI of Exhibit / PPQ batch, MI of registration and bio batch, \xc2\xb7 SOPs etc. and other GMP related documents.Accountability : \xc2\xb7 Execution of feasibility, development, registration, exhibit / PPQ batches and Pilot bio-batches. \xc2\xb7 Timely initiation of procurement of Raw material, API, change parts for new product development / existing API source variation product. \xc2\xb7 Timely respond regulatory query for new product filing. \xc2\xb7 Timely completion of investigations and reports on OOS, Deviation and their Compliance including Implementation and / or closure of all Change requests, CAPA. \xc2\xb7 Involvement in internal and external audit and timely response against observations. \xc2\xb7 Management of ware house inventory and their timely transfer for commercial utilization after completion of project. \xc2\xb7 cGMP compliance in Master Documentation. \xc2\xb7 Other assignments, as assigned by the superior.Customers : Internal: Quality Assurance, Quality Control, NPQC, Manufacturing, Validation, Stability, Engineering, Regulatory Business Community, Warehouse & EHS. External: Corporate Quality Assurance, Corporate Regulatory Affairs, R & D, Visitors / auditors.

Sun Pharmaceutical Industries