Production Manager

2 months ago

kota, India Acme Generics Full time

Responsibilities:

  • Conducting operation at plant as per GXP norms and all regulatory, legal and laws related to the plant.
  • Operating plant activities as per written procedure/policy, campy and ensuring online documentation.
  • Providing technical and administrative support to HR, Warehouse and Engineering, IT for Production smooth of the plant.
  • Ensuring all operation is conducted using trained manpower with online documentation by maintaining accurate data.
  • To conduct all the operations in the plant as per ‘Schedule M’, EU GMP & other regulatory standards as per the intended business plan.
  • To review existing system and upgrade to intended regulatory standards.
  • Investigating, training the people and implementing suggested CAPAs.
  • Providing necessary welfare services to all personnel at site and to ensure fair treatment to all.
  • To review employee performance periodically and suggest suitable remediation plan.
  • To ensure to keep the plant equipment and instrument in qualified & calibrated state prior to use.
  • To coordinate with Quality, R&D and business development team to produce the products as per agreed production plan.
  • Ensuring GXP training to the staff and workers.
  • Coordinate with commercial department to ensure all RM, PM and Consumables are made available for required plan.
  • To provide required manpower & operate the plant in cost effective manner and to be within the allotted budget.
  • To intimate the HOD with respect to Abnormalities /miss happening / incidents / Deviations on time.
  • To follow the proper documentation procedure with respect to data integrity (ALCOA+) every time & also responsible to maintain the safety of DATA inside the factory premises.
  • To act as responsible person for operation during all regulatory/client / financial audits.
  • To monitor & support technology transfer & any trouble shooting/ investigation in timely manner from In-house R&D or client end.
  • To promptly work with management and quality assurance department in situation of product recall, field alert or any regulatory process which is affecting patient health & ensure compliance for the same.
  • To maintain confidentiality of the company documents & intellectual properties.
  • To execute any other job allotted by management in timely manner
  • To monitor effectiveness utilization of the optimum resources.
  • To participate in finalization of capex, opex & manpower budget for the site

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