To prepare, review, approve and distribute the instructions for the production of intermediates or APIs according to the written procedures.
To produce APIs and/ or intermediate according to the approved instructions.
To review all production batch cards for correctness and ensure that these are complying the DI principles and signed.
To ensure that all production deviations are reported and evaluated on time, critical deviations are investigated and the conclusions are recorded as per standard procedure.
To ensure that production facilities including critical utilities (if applicable) are clean and fit for use.
To ensure that the necessary calibrations/verification are performed and records kept.
To ensure that the premises and equipment are maintained and records kept.
To ensure that validation protocols and reports are reviewed and approved.
To ensure that new and modified facilities and equipment are qualified as per approved procedure.
To ensure appropriate training is given to employee as per approved procedure.
Responsible for the implementation and assimilation of cGMP and safety.
Tracking of day-to-day production activity.
How you’ll spend your day
Troubleshooting & debottlenecking of the plant activities.
To review the availability of raw material in warehouse for planned production.
Review the Open order & plan the production activity accordingly.
Close monitoring of RMC of product against the standard norms.
Preventive maintenance schedule compliance & its planning.
Controlling of overtime by proper leave planning.
Controlling of the usage of water & pretreatments of waste/spent water.
Minimization of solvent exposure to air pollution.
Hazop study & implementation of Hazop recommendation.
Monitoring of OEE & ERP.
Maintenance of plant machinery & building in coordination with Engg.
Intradepartmental coordination with service departments.
To organize proper segregation of plant waste for safe disposal.
As a functional manager accountable for Opex implementation in respective area and support to Opex champion for his initiatives.
As an Opex champion, identification of improvement projects in respective areas and supporting functional head to implement the project with targeted OTIF.
Estimating the base line performance and implementation of Opex in respective areas to achieve the targeted continuous improvement in cost, quality, compliance and EHS.
Monitoring and review of energy consumption in respective areas and initiating the CAPA if it is out of trend/ off the track.