#Involved in installation, commissioning and validation all critical equipment, system as per cGMP norms (DQ, FAT, SAT, IQ, OQ and PQ). #Qualification of different types of vendors who supply ‘Raw material, Primary packing material, medical devices, #Creation of the URS, technical comparison and technical discussion of the various equipment required for the project. #Involved in Qualification of SAP. #Involved in Area qualification and process simulation. #Working closely with project team to build state of the art manufacturing facilities which complies with US/EU and local norms and getting the various Statutory approvals. #Procurement (including CAPEX handling) and project management of Vial Filling lines (Tofflon) for aseptic processing, lyophilizer with ALUS (Tofflon), Autoclaves.#Conducted FAT for all the machines like Isolators, Filling machines, Vessels and CIP/SIP system, Packaging lines, lyophilizer etc. #Installed all the equipment’s at site and execution of all the qualification activities like SAT, IQ, OQ, PQ and media fills. #Design of single use systems for the formulation process and the filling process. #Technology transfer from the Process development to the manufacturing facility for various product and making the facility suitable for scale up, engineering and process validation batches. #Successful completion of audits like USFDA, TGA, EMA. and customer audit like DRL, SUN pharma, Biocon, Emcure. Etc.

• Monitoring of daily operations like compounding, Filtration, Filling, Lyophilization, visual inspection activities and ensuring the completion as per the time line.• Ensuring all the activities are carried out in compliance with GMP and no data integrity issues during the execution of activity.• Review of executed BMRs, log books & supporting documents and its compliance.• Review and implementation of SOPs.• Preparation of shift schedule and allocation of work to operators as per plan.• Handling of incidents / Deviations.• Co-ordinating with QA, QC, Warehouse, Engineering for day to day operations.• Executions of Media fill activities as per schedule.• Conducting the SOP trainings for operators and team members.• Successful completion of audits like ANVISA, JFDA.MHRA• Exposure to Isolator and RABs system.

Manufacturing :-• Supervising the Raw material dispensing, Formulation, Filtration activities and achieving the target as per production plan.• Online updation of Batch manufacturing records and log books.• Assisting to production manager to prepare the monthly production plan.• Review and implementation of SOPs and Batch manufacturing records.• Handling of deviation and CAPA.• Ensuring the calibration of instruments used in the manufacturing area as per schedule.• Execution of Aseptic Process Simulation for Vial, Ampoules, pre filled syringes and Lyophilization process.• Co ordinating with R&D department for developmental batches.• Interacting with cross functional departments for the smooth flow production activities.• Giving the training to operator with regard to cGMP and clean room behaviour.• Co ordinating to validation team for validation activities.• Supervising the disinfectant preparation activities and ensuring the production area is cleaned as per frequency.

A) Production Activities:• Carrying out the formulation as per batch manufacturing record.• Sterile filtration of prepared drug products.• Operation and trouble shooting of Vial, cartridge and syringe filling Machine.• Operation and trouble shooting of Vial Sealing Machine.• Operation and trouble shooting of Vial Washing and sterilizing tunnel.• Performing the integrity testing for the filters.• Performing the Aseptic Process Simulation process for vials , syringes and cartridges.• Sterilization for machine parts, rubber stoppers, silicone tubing’s, etc. for aseptic filling activity.• Carrying out the machine changeover for different change parts as per product requirement.• Dispensing of raw material and primary packing materials.• Co-ordinating with warehouse for raw material and primary packing stock details.• Co-ordinating with engineering department for the preventive maintenance schedule.B) Lyophilization:• Defrosting.• CIP and SIP.• Leak Test.• Loading the Recipe as per BMR.• Monitoring of cycle as per frequency• Coordinating for the validation of Lyophilizer. C) Validation:Carrying out the following equipment validation coordinating with respective departments• Autoclave.• Sterilizing Tunnel.• Lyophilizer.D) Documentation:• Preparation of Standard Operating Procedures, Equipment Operating Procedures, Instrument Operating Procedures, and Equipment Cleaning Checklist related to Production department.• Review of executed BMRs, logbooks, checklist and compiling the data.• Handling of change controls, deviations (planned & unplanned), incident report, related to manufacturing process.• Maintaining of all documents related to manufacturing area as per cGMP• Maintaining the daily logs of the process area and co-operating with rest of the team for the successful audits.