Department Details Production API Role Summary Production API Key Responsibilities
Authorized to Operate the Equipments and instruments through DCS system / manual
Responsible for Clean the equipment/accessories as per equipment cleaning checklist / approved procedures
Responsible for all the manufacturing operations as per respective BMR /PDR / SRR / Checklist / routine monitoring and recording of documents as per approved procedures.
Responsible for receiving, dispensing, storage, packing of Raw Material / in process materials / Finished product
Performing necessary calibration / verification and recording of documents as per approved procedures
Performing production activities as per standard operating procedures .
Ensuring preventive maintenance and instrument calibration are within due dates.
Maintaining equipment surface area in cleaned condition.
Online updation of logbooks / status board and other record with respect to area / equipment / accessories.
Co -ordination with QA for line clearance during product change over
Co-Ordination with other department related to production activities
Handling of procedure and shut down & startup in production facility
Maintenance of Production equipment in coordination with Instrumentation / Engineering and maintenance Department and Handling of work permit system
Adhering to EHS policy and safety guidelines Zero tolerance policy and Code of conduct policy, Adherence to Good manufacturing practices, Adherence to Quality Policy and Quality Management System
In-process product sampling, inspection and storage.
Responsible for performing the audit trail review.
Authorized to initiate the login for QMS related activity , like Initiation, coordinating CFT and providing supporting documents for all QMS related documents Change control, deviation, OOS, OOT, CAPA, audit management, Etc.,
Review and submission of executed documents like BMR, ECC,checklist, logbooks,annexures etc.,to QA.