DGM - Production

Role & responsibilities

• Responsible for manufacturing activities of all the commercial manufacturing blocks, 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, risk assessments & regulatory 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, motivation of every employee in plant and maintaining 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.

Educational Qualification : B Tech- Chemical / M Sc. Chemistry

Experience : 20+ Years