Gaurav Pathak Email & Phone Number

United Arab Emirates

Production Responsibilities• Follow and Implement the cGMP & GDP to meet the regulatory requirement• Responsible for all associated Operations (Fill Finish &Packaging) & quality Systems in the Production area.• Preparation review and approvals of process-related documents like BMR, BPR, SOP, Formats logbooks, and study protocols• Checking the production materials like RM, PPM.SPM and planning for production.• Planning & Execution of Production Schedule (Formulation, Filling… Show more Production Responsibilities• Follow and Implement the cGMP & GDP to meet the regulatory requirement• Responsible for all associated Operations (Fill Finish &Packaging) & quality Systems in the Production area.• Preparation review and approvals of process-related documents like BMR, BPR, SOP, Formats logbooks, and study protocols• Checking the production materials like RM, PPM.SPM and planning for production.• Planning & Execution of Production Schedule (Formulation, Filling Packing).• Preparation of Production plans according to the Sales forecast.• Effectively work within a cross-functional team to complete critical project tasks.• Preparation, revision & training of all required SOPs for the department.• Planning Manpower and arranging the shift Schedules.• Arranging the area cleaning Schedules and providing the proper disinfectants for area cleaning.• Maintaining the state of clean-rooms Class-A & Class-B areas.• Proper training for the aseptic operator for personnel behavior in clean rooms. Training the Employees on the Job Roles.• Prepare and make ready the facility for regulatory audits.• Prepare URS for the new Vaccine facility.• Perform Media fill simulation.• Support CIP and SIP validation programs as necessary.• Experience in Handling QMS tools like Change Control, Deviations, Exception, CAPA, etc.• Review of batch records, addressing discrepancies and escalating where required.• Writing, reviewing, and proposing new and updated SOPs and processes in order to improve the QMS and related systems.Instruments Technical Skills Experience in Production related Troubleshooting of the following types of equipment:Vial/Ampoule washing machine (Make: Bausch + Strobel),Weighing BalanceVial/Ampoule filling machine (Make: Bausch + Strobel,),pH MeterVial/Ampoule Sterilizing & Depyrogenation Tunnel (Make: Bausch + Strobel),Dynamic Pass BoxAutomatic Visual Inspection (Make: Brevetti) Portable vessels Show less

United Arab Emirates

1. Responsible for manufacturing methods “MFM”, process flow charts, process description and in-process control check tests.2. Manage all the materials requirements for production through coordination with warehouse Manager.3. Coordinate with Sale achievement manager to adhere with the plan and fulfill the market Requirements.4. Responsible for Premises maintenance, Equipment, Consumable lists.5. Coordination with the Engineering department for all Engineering work: HVAC, Water… Show more 1. Responsible for manufacturing methods “MFM”, process flow charts, process description and in-process control check tests.2. Manage all the materials requirements for production through coordination with warehouse Manager.3. Coordinate with Sale achievement manager to adhere with the plan and fulfill the market Requirements.4. Responsible for Premises maintenance, Equipment, Consumable lists.5. Coordination with the Engineering department for all Engineering work: HVAC, Water system, calibration, Validation.6. Perform and oversee cGMP activities within production areas (Grade A, B, C).7. Subject Matter Expert and key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular audits and any other interaction with regulatory agencies.8. Initiate investigation and handling of deviations and prepare response based on investigation findings and implementation of CAPA.9. SME author of Deviations, CAPAs and Change controls relating to manufacturing activity, through Amlpelogic (Web based software for eQMS).10. Review all calculations related to the manufacturing process and material requisitions.11. Supervise all dispensing and preparation of the cold chain (2-8ºC) products Insulin (short acting, intermediate acting and long acting) and Erythropoietin products.12. Ensure the CIP/SIP of tank.13. Monitoring operations of cartridge washing m/c, depyrogenation tunnel & filling (Baush & Strobel), steam sterilizer (Fadegari),visual inspection and labeling system.14. SME author/reviewer for written procedures, SOPs , MFM, repots, Job description, training records.15. Executions of the media fill study for injection.16. Monitoring of Critical process parameter (CPPs) and trouble shooting in the Insulin formulation process.17. Monitoring of personal hygiene of all operators working in all section.18. To prepare and submit daily reports to Technical Director. Show less

United Arab Emirates

Injectable plant management (insulin vial and Erythropoietin vial preparation plant)To receiving, dispensing of raw material and preparation of the batch as per batch manufacturing record. Responsible for preparation of the cold chain (2-8 degree) products Insulin (short acting, intermediate acting and long acting) and Erythropoietin products. Filling of entries in log sheets & Batch manufacturing records. Executions of the media fill study for injection. Ensure the… Show more Injectable plant management (insulin vial and Erythropoietin vial preparation plant)To receiving, dispensing of raw material and preparation of the batch as per batch manufacturing record. Responsible for preparation of the cold chain (2-8 degree) products Insulin (short acting, intermediate acting and long acting) and Erythropoietin products. Filling of entries in log sheets & Batch manufacturing records. Executions of the media fill study for injection. Ensure the CIP/SIP of tank, Filling machine and Lyophilizer. Monitoring operations of vial washing m/c & depyrogenation tunnel (Baush+Stroble), steam sterilizer(Fadegari). Monitoring of personal hygiene of all operators working in all section. Regular monitoring of critical parameters such as temperature, humidity, pressure differential of area. Preparation and updating of batch manufacturing records and S.O.Ps. To ensure the maintenance and validation of production equipments. To provide required training to production technicians and sub-ordinates. To comply with the requirements of cGMP. Up gradation of area and equipment as per Audit. Handling of change control and deviations. To prepare and submit daily reports to Department Head. Show less

United Arab Emirates

 To receiving, dispensing of raw material and preparation of the batch as per batch manufacturing record. Responsible for preparation of the cold chain (2-8 degree) products Insulin (short acting, intermediate acting and long acting) and Erythropoietin products.  Filling of entries in log sheets & Batch manufacturing records. Executions of the media fill study for injection. Ensure the CIP/SIP of tank, Filling machine and Lyophilizer. Monitoring operations of vial… Show more  To receiving, dispensing of raw material and preparation of the batch as per batch manufacturing record. Responsible for preparation of the cold chain (2-8 degree) products Insulin (short acting, intermediate acting and long acting) and Erythropoietin products.  Filling of entries in log sheets & Batch manufacturing records. Executions of the media fill study for injection. Ensure the CIP/SIP of tank, Filling machine and Lyophilizer. Monitoring operations of vial washing m/c & depyrogenation tunnel (Baush+Stroble), steam sterilizer(Fadegari). Monitoring of personal hygiene of all operators working in all section. Regular monitoring of critical parameters such as temperature, humidity, pressure differential of area. Preparation and updating of batch manufacturing records and S.O.Ps. To ensure the maintenance and validation of production equipments. To provide required training to production technicians and sub-ordinates. To comply with the requirements of cGMP.  Up gradation of area and equipment as per Audit. Handling of change control and deviations. To prepare and submit daily reports to Department Head. Show less

Hyderabad Area, India

 Responsible for granulation activity receiving and verification of raw material and prepare the batch as per batch manufacturing record. Responsible for batch start up of capsule filling operation and in process checks (Imatic 200 & Bosch GKF 2500). Responsible for executing the production target of the module as per the production schedule. Ensure that daily production schedule is followed, and communicated to the workers. Responsible for strict adherence to the standard… Show more  Responsible for granulation activity receiving and verification of raw material and prepare the batch as per batch manufacturing record. Responsible for batch start up of capsule filling operation and in process checks (Imatic 200 & Bosch GKF 2500). Responsible for executing the production target of the module as per the production schedule. Ensure that daily production schedule is followed, and communicated to the workers. Responsible for strict adherence to the standard operating procedure (S.O.P) and cGMP requirement. Responsible for online completion of batch records. Cross checking of Documents like batch card, log books, etc. online. Responsible for process validation. Responsible for Installation /Commissioning of New Machines. Initiate and conduct investigations for performance, quality or safety related incidents and complete documentation. To ensure that all the Workers are wearing adequate PPE at the time of manufacturing. Manage the effective deployment and utilization of staff, monitoring labor hours and costs, including overtime. Responsible for implementing the productivity improvement measures. Active participation in various Audit preparations, development and implementation of various training, attends safety, and quality programs. To implement and follow the procedures for efficient functioning of the machines. Ensuring dispatch and dispensing of product on time. Maintain industrial relation in to department. Show less

India