Title:  Production Head - API

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