Must have experience in injectable production/ manufacturing & regulated plant.
To do on line operation checking and ensure online entries in Batch Manufacturing Record (BMR), log books & related documents as per Standard Operating Procedure (SOP)
To supervise manufacturing activities i.e. sterilization, mixing, filling in allocated shifts and ensure process adherence as per standard operating procedure (SOPs)
To co-ordinate with Production Planning & availability (PPA), Engineering services, Quality Assurance (QA) & Quality Control (QC) for smooth functioning of process.
To ensure all the equipment in the department are in validated and calibrated status.
To effectively manage the manpower, machines and materials in order achieve optimum output.
To prepare Daily production report & Management Information system (MIS) & send it to Line Manager.
To educate the staff for yield norms to check the yield at various operation points, to improve the result through correct implementation of SOP and suggest changes to Manager, if required.
To ensure proper planning and execution of the batches in accordance with the plan.
To give training of current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) is given to team members periodically as per defined schedule.
To handle Change management, Deviation management and OOS investigation in co-ordination with Quality Assurance (QA) Department
To co-ordinate with Engineering & Technical departments for the plant related repair, maintenance and Preventive maintenance work.
Claris Lifesciences is an Indian sterile injectables pharmaceutical company with a... market presence across 100 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses. Read full description