Position:

Deputy General Manager

 

 

Job Title:

DGM-Production (API)

Job Grade:

DGM – G8

Function:

API Manufacturing

Sub-function:

Production

Manager’s Job Title:

Plant Head

Skip Level Manager’s Title:

VP-Operations

Function Head Title:

Plant Head

Location:

Toansa

No. of Direct Reports (if any)

5

 

 

 

 

 

 

 

Areas of Responsibility

 

Job 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 API’s 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 & API’s. 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 & API’s 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.

 

 

 

 

 

 

Travel Estimate

Less