Job Description

RESPONSIBILITY:Coordinate procurement activities for RM materials & Tooling\'s.Preparation, Review and approval of relevant documents for Dummy/Feasibility batch, Exhibit/Test batch, TTD, Pre PPQ and PPQ batches and other documents required for Regulatory filings.Example: Formulation order, Manufacturing Instruction, Process development Protocol/Report, Test batch Monitoring Protocol/Report, IPHT protocol/Report, Pre PPQ and PPQ Protocol and report.Response to regulatory in query responses.Preparation and maintenance of Material Master, Recipe and Bill of material in System Application & Products in data processing (SAP) and creation of reservation.Creation / extension / deletion / updation of SAP codes and to carry out SAP related activities related to MSTG.Timely initiation, review and closure of Change control, Deviation, Investigation, CAPA etc. in trackwise.Tracking of deviations, Change controls & CAPA closure.To prepare and review Standard Operating Procedure (SOP) related to MSTG.Providing response to internal and external audits and Regulatory query responseReview and approval of Continuous Process Verification reports, Post PPQ Protocol & Report, Annual Product review, Summary report to stage 1 of Process validation, stability protocols, URS, Equipment qualification protocol/reports.Departmental training coordinator for monitoring activities in LMS trainingIn absence of Job holder Sr. Officer / Executive/Research Manager - MSTG will be responsible for above stated /identified responsibilities.

Sun Pharmaceutical Industries