Ramesh Kumar Sonker Email & Phone Number

Iceland

Reykjavík, Capital Region, Iceland

Commissioning Qualification and Validation

Bengaluru, Karnataka, India

Green Field Project (Sanofi Pasteur Toronto Canada). Vaccine manufacturing Facility Support a front office team based in Toronto, Canada towards executing the complete project scope of work. Preparation Review and approval of SOP. Preparation and Review of Validation Protocol’s (URS, RTM, CTP, CTS’S (IV, SUSD & OV), QSR and PQ for the following systems as Air Handling Systems (AHU’S) Autoclave, CIP & SIP Systems, Fermenter’s, Incubator’s, Isolators, Laminar Air Flow Systems, Biosafety Cabinet etc. Manage the Qualify, Delivery and Creation of the following work packages based on document templates and information provided by the front office: Required traceability matrix (RTM) – Trace all approved requirements, specifications & test protocol. Commissioning Test Protocol (CTP) – Include Commissioning Test Script (CTS) capturing IV, Start-up and shake down (SU/SD) and Operational Verification (OV). Commissioning Test Report (CTR) – Summarize CTP execution results of GxP System. Qualification Summary Report (QSR) - Summarize CTP execution results of Non GxP System. Performance Qualification (PQ) – Validate the performance of Clean Utility Systems. Study and analyze relevant documents required to produce and deliver the work package as effectively as possible. Proactively notify the front office team of any information required or missing which could directly influence the content and quality of the work packages. Arrange and participate client alignment meeting as required to fine-tune the content of the work packages. Set and continually manage work package expectations with the front office team members.Plan, Schedule and Track Progress and Milestones to provide the information to the front office team, as required.

Bengaluru, Karnataka, India

Ahmedabad Area, India

To Prepare protocol for PV equipment and utility and send it for approval .To conduct FAT for new equipment’s.To Review process validation, qualification planner.To prepare qualification documents like Gxp Assessment, URS, DQ, FAT, SAT, IQ, OQ, PQ and stage wise risk assessment.To prepare departmental SOP’s To carry out compilation and review of all validation docs.Preparation for audits and inspection readiness.Preparation of investigation of QMS elements.To ensure implementation of validation, qualification activities and inform section head for any deviation from written procedure.To Coordinate among various department for process validation and qualification activities.To train the subordinate on various aspects of GMP etc.To contribute team spirit and guide the team starting from preparation and execution and till the preparation of validation report.To keep the facility updated from GMP aspects as per regulatory expectation.To fulfill the responsibilities given by Head of department as and when required.

Halol, Gujarat, India

Halol

• In Sun Pharma I am looking over Anti Cancer Block for Qualification related Activity following are the my Key Responsibilities.• Co-ordination with user department for execution of qualification activities at the site.• Provide training to all concerned on qualification activities.• Reporting of any variance occur during qualification activity.• Introduction of new product assessment.• Ensure the current regulatory requirement of the equipment and qualification documents.• Preparation and Review of Qualification & Requalification protocols like URS, FAT, DQ, SAT, IQ, OQ, PQ& RQ.• Equipment Qualification & Requalification Activity:-Qualification and Requalification of following equipment’s& utilities:• Compilation and Review of executed reports.• Review of the layouts and other documents during qualification.Preparation of Summary Report for regulatory submission. Steam Sterilizer (Autoclave), Tunnel, Vial & Ampoule Washing Machine, Freeze Dryer, Vial & Ampoule filling machine, Infusion Bag Filling Machine, Infusion Bag Leak Test Machine, Manufacturing Tank, CIP & SIP Skid, Deep freezer & Cold Room, LAF, Dynamic Pass Box, Dynamic Garment Storage Cabinet, HVAC System & Area Qualification etc.• • Handling of Deviation, Change Control& Incident etc.• Handling of QMS Software FMS (Form Management System), LMS (Learning Management System), Document Coder& Trackwise.

Paonta Sahib Himachal Pradesh

1. Validation & Qualification activity Perform and coordinate Equipment Validation HVAC Validation LAF and RLAF Validation Dynamic pass box & dynamic garment storage cabinet. Hot air oven validation Heating Block validation Dry heat sterilizer validation Washing Machine Validation  Manufacturing Tank Calibration Vertical and horizontal Autoclave Validation Sterilization and Depyrogenation Tunnel Validation Process Validation Media Fill Validation2. Documentation and shop floor Activity To ensure GMP Compliance in the Production areas.  To review BMR, BPR, Log Register and Daily record on the shop Floor.  To prepare and review the Documents like Standard Operating Procedures and other Documents.  To carry out IPQA activities in each stage of Manufacturing and Packing.  To ensure Line Clearance during Batch/ Product Change Over.  To carry out sampling activities.  To execute Qualification/ Validation activities of process equipment, utilities and prepare its documents.  To prepare the Product Quality Review.  To check and monitor the training records.  Logging and Closing of Change Controls/ Deviations/ Incident/Market Complaints etc.  Preparation of APR.3. Handling of Validation Equipments:- KAYE VALIDATOR (Amphenol) for thermal validation Aerosol Photometer and Aerosol Generator (Tech Services) for HEPA integrity  Anemometer Vane Type (Lutron) for air velocity Non Viable Particle Counter (Met One) for non viable particle count

Hardwar

Preparation validation protocols and other documents.Validation and execution of production system like Autoclave, Tunnel, HVAC validation, washing machine validationetc.Nitrogen system validationMedia Fill ValidationSee all IPQA activity in sterile and non sterile area.See terminal inspection .