Manager / Sr. Manager Production ( API )

le & responsibilities

Operations, Control and Monitoring

• Resolution and identification of maintenance related activities of equipment and facility and making sure those are closed appropriately.
• Preparing production plan and supervising the API and Intermediate batches as per production plan.
• Monitoring and controlling of effluent generation from manufacturing block.
• Periodic review and monitoring of inventory in coordination with Supply Chain.
• Conduct vendor audits in order to procure quality material.
• Control and monitor Departmental Opex budget.
• Ensure development of products related to Flow chemistry in R&D and smooth technology absorption from R&D.
• Support equipment mapping, modifications requirement identification, execution and troubleshooting of products.
• Ensure Facility upkeep is maintained all the time.
• Identify the improvement possibilities for product, process or equipment and facility.
• Prepare and execute the action plan for the implementation of improvements identified for product, process or equipment and facility.
• Actively participate in incident investigations by coordinating with CFT to identify the actual root cause and derive at CAPA.
• Ensure CAPA implementation and its effectiveness check.
• Executing and monitoring of validation of new product
• Identifying and implementation of new technology w. r. t., process equipments or facility.
• Supporting Quality assurance team for DMF submission.
• Communicating concerns with Cross functional and service departments.
• To Conduct Risk analysis of product, system, equipment, process as per standard procedure.
• To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.

GMP

• Following departmental standard operating procedure (SOP) and providing suggestions for SOP simplification and any other improvements.
• Making sure all the documents and checklist are verified before and after manufacturing.
• Ensuing Retention and destruction of records are done with the help of Quality Assurance.

QMS

• Operating software systems like SAP, Quality Management System, DCS System, track wise system, etc. based on roles and rights provided in the applications.
• Compiling Annual product quality review along with quality assurance department and other CFT.

EHS

• Following Environment, Health and safety policies and practices.
• Making Sure personnel health, hygiene and organisation practices are followed.
• To Conduct Risk analysis of product, system, equipment, process as per standard procedure.

Training

• Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).

Energy Management system (EnMS)

• Participating in EnMS audits & Leadership rounds.