24 Oct
Acme Generics
Davanagere
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
▶️ Production Manager
🖊️ Acme Generics
📍 Davanagere