Akums Drugs & Pharmaceuticals Pvt Ltd.

Role & responsibilities Responsible for manufacturing Operation like API manufacturing Sterile API manufacturing by aseptic process, Purification by preparative HPLC, Peptides. Managing all shift activities like Day-to-Day batch planning, in- process checks with team, dispensing, packing, repacking of API. Responsible to trained subordinate, colleagues. Implementing and achieving highest standard of cGMP and WHO. Excellent communication with all inter-departments like warehouse, QC, QA, Engineering, R&D, PD Lab and ARD for smooth functioning and execution of production activities. Trouble shooting during execution of pre-validation batch and finding robust solutions for the problems before validation batches to avoid the failures and to get consistent yield and quality at commercial scale. Ensure all time Plant readiness for inspections, audits by customer and regulatory authorities. Recruit and train successful multi-cultural teams with latest knowledge & modern skills in technical support fields to deliver quality services. Selection of the suitable equipments, maintain and upgrade manufacturing facility as per Production, safety and cGMP requirement. Monitoring safe work environment and maintain good house keeping. Documents preparation, Review like SOP, MBR, ECR, Protocol, Reports, Qualification. Responsible for QMS Activity (Change control, Deviation, CAPA, Risk Assessment). Responsible for Qualification activity of Isolator (Closed Containment System), Autoclave, SIP process, VHP cycle. Responsible for process designing of Media fill accordance to New Product Introduction