Production Manager

6 days ago

Baddi, 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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