Executive - Mstg

Job Role : Executive - Manufacturing Science and Technology Group

Essential function of the

Job : - Timely and successfully execution of Placebo, Feasibility, Process development, Registration, Pilot Bio, Exhibit and PPQ Batches. - Documentation for Feasibility / Process Development / Registration / Pilot Bio / Exhibit batches / PPQ batches. - Procurement of change parts / RM. - Ensure compliance to cGMP / Regulatory requirement. - Resolve Filing related queries.

Training Required : As per the approved training matrix for functional Responsibilities.

Relationship with

Superiors : 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 basis

Reporting to : Senior Research Manager (MSTG)

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Job Responsibilities : - To ensure planning and procurement of change parts, raw materials. - To ensure Co-ordination and timely execution of feasibility, process development, registration, exhibit, pilot bio
- batches & PPQ batches. - To ensure SOP & cGMP compliance in Master Documentation. - To maintain review of master batch production records and SOPs. - To ensure QMS activities
- Initiation and tracking of proper documentation of Deviation, OOS, Change controls and implementation of CAPA. - To ensure the quality, purity, safety, identity of drug product in accordance with MI. - To monitor and cross check the manufacturing activities and cleaning activities in different process areas. - To maintain and control the RM warehouse inventory of MSTG at Paonta sahib Location. - To maintain FO/MI’s, Protocols, Reports, TDP and Technology transfer dossier. - To take care MDN Creation of expired raw material (Excipients & API) of PDL warehouse. - 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 of

Documents : - Protocol and reports of feasibility study trial batch, process development batch, Exhibit/ PPQ batch, in-process holding time study, - FO/MI of Exhibit/ PPQ batch, MI of registration and Pilot bio batch. - Change control related Process Development Batch, Registration, Exhibit, PPQ batch, Pilot bio batch, - Initiation of Track-wise Documents [PD, UPD, Investigations, CAPA, Change Controls], - Creation/extension/deletion of RM, API & INTM code in SAP, - Initiation of reservation/PO of material in SAP for feasibility batch and process development batch. - Initiation of purchase request, - Initiation of checklist for new molecule introduction to the site and exhibit batch. - Initiation of Code to Code Transfer Requests, - Specification Linkage Requests and Self-life and retest period extension. - Initiation of analytical request for feasibility batch, process development batch, exhibit/ PPQ batch, registration batch, bio-batch. - 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. - Initiation of SAP related activities (Vendor locking and Recipe creation). - Other assignments, as assigned by the superior.

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Review of Documents : - Review of Protocol and reports of feasibility study trial batch, Process development batch, Registration, Exhibit and PPQ batch, in-process holding time study, - FO/MI of Exhibit / PPQ batch, MI of registration and bio batch. - Review & Approval of SOP’s.

Approval of

Documents : - Protocols and reports of feasibility study trial batch, process development batch, exhibit / PPQ batch, in-process holding time study, cleaning validation. - FO / MI of Exhibit / PPQ batch, MI of registration and bio batch, - SOPs etc. and other GMP related documents.

Accountability : - Execution of feasibility, development, registration, exhibit / PPQ batches and Pilot bio-batches. - Timely initiation of procurement of Raw material, API, change parts for new product development / existing API source variation product. - Timely respond regulatory query for new product filing. - Timely completion of investigations and reports on OOS, Deviation and their Compliance including Implementation and / or closure of all Change requests, CAPA. - Involvement in internal and external audit and timely response against observations. - Management of ware house inventory and their timely transfer for commerc