**Position:** Deputy General Manager **Job Title:** DGM-Production (API) **Job Grade:** DGM G8 **Function:** API Manufacturing **Sub-function:** Production **Managers Job Title:** Plant Head **Skip Level Managers Title:** VP-Operations **Function Head Title:** Plant Head **Location:** Toansa **No. of Direct Reports (if any)** 5 **Areas of Responsibility** **Job Responsibilities:** + Responsible formanufacturingactivitiesofallthecommercialmanufacturingblocks, ensuring compliance to cGMPs, safety procedures, current SOPs, statutory guidelines and company's code of conduct in the plant. + Ensuring delivery of scheduled production as per the plan meeting quality and cost Parameters. + Ensuring that all the projects are completed in the given time frame and within the allocated resources. + Evaluating opportunities for reduction of waste generation, water wastage and fugitive emission. + Ensuring availability and updating of all relevant process, regulatory, statutory, engineering documents in the module. + Ensuring production activities are performed as per approved written down procedures. + Ensuring the cost of manufacturing within standard yields & usages and continuous effort to decrease the product cost. + To ensure simplification and improvement of present manufacturing processes through continuous development work + Issuance of the Batch Production Records & batch record of cleaning (BRC) for production of intermediates or APIs according to current SOPs. + Reviewing all Batch Production Records & batch record of cleaning (BRC) and Ensuring that these are completed and signed. + Approval of MPR's/ECR's in eBMR printing Module. + Review of new/revised MPRs and validation protocols and reports. + Performing authorized SAP, Track wise CAPA, LMS & DCM activities. + Reviewing & approving of SOPs as assigned. + Preparing/Reviewing of risk impact analysis, risk assessment & risk re-assessment. + Reviewing the trend of Quality and production parameters of intermediates & APIs. + Ensuring that all production deviations are evaluated and all critical deviations are investigated as per current SOPs. + Investigating OOS, Market complaints and OOT of intermediates & APIs and conclusion are recorded on time. + Planning & implementation of CAPA actions arises out of investigations, observations, riskassessments®ulatory observations. + Ensuring necessary calibrations and records are maintained. + Ensuring timely maintenance of equipment & facility and records are maintained. + Evaluating the proposed changes in the product, process and equipment for quality and productivity improvements. + Qualifying new or modified facilities and equipment as per current SOPs. + Ensuring compliance to cGMPs, safety procedures, current SOPs, statutory guidelines and Company's code of conduct in the plant. + Training and development of subordinates and indulge in learning and self-development. + Maintaining discipline, morale, motivationof every employeeinplant andmaintaining harmonious industrial relations. + Ensures verification of document destruction records prepared by the document Coordinator. + Preparation and maintenance of annual budget for plant. + To ensure that the manufacturing efficiencies are achieved as per the budgeted plan. + Maintaining product quality and yield as per norms. + Practicing company values in all aspects of work. + Preparation of Product development report and cleaning procedure development report. + Ensuring production facilities are clean and disinfectant where required. + To sign off documents/TrackWise records as HOD/Function Head role. + To ensure the batch production order must be verified before its issuance, to ensure that be the correct version of the standard/master formula. + To ensure that equipment is calibrated and qualified and maintenance is carried out. + To ensure the issuance, revision, replacement, withdrawal and distribution of documents must be controlled. **Travel Estimate** Less We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.