Gone Pruthvi Email & Phone Number

Andhra Pradesh, India

Hyderabad, Telangana, India

Assistant Manager - Validation (Equipment/Utility qualifications and Miscallaneous validations) To lead the Validation team (Projects) with compliance of regulatory requirements In any team member absence, I also act as a team member and take the responsibility for the below activities  Monitoring and execution of qualification activity (URS, FAT, SAT, DQ, IQ, OQ, PQ and RQ). Responsible for Preparation, Execute, Review and Summarization of Utility Qualification Protocols. Preparation, Execute, Review and Summarization of all Process Equipment qualification Protocols  Preparation, Review and Summarization of Sterilization Validation Protocols & Reports Responsible for Preparation, Execute, Review and Summarization of Transport validation.  Responsible for Engineering Assurance and responsible to review Preventive Maintainance, Calibration Checklists, Schedules, Logbooks Preparation of Maintaining of VMP of Equipment qualification and other validations to ensure the completion of activity within due.  Preparation, review and Summarization of the Periodic qualification Protocols and Summary. Preparation , Review and summarization of Miscellaneous study protocols Responsible for ensuring cGMP compliance on working floor and to prepare for all time readiness environments for audit preparation.  Coordination with various departments for commencement of above Qualification activity To involve the investigation of validation related discrepancies and Preparation, Review of investigation report. Handling of CAPAs, Change controls & Unplanned,Planned deviations related to validation. Technical write up as justification/rationale for validation activities for any internal/external audit observations

Hyderabad, Telangana, India

Plot No: 4,34 To 48, Phase-Iii,Epip,Tsiic, Pashamylaram, Sangareddy Dist, Telangana

Assistant Manager - Validation (Equipment/Utility qualifications and Miscallaneous validations) To lead the Validation team (Projects) with compliance of regulatory requirements In any team member absence, I also act as a team member and take the responsibility for the below activities  Monitoring and execution of qualification activity (URS, FAT, SAT, DQ, IQ, OQ, PQ and RQ). Responsible for Preparation, Execute, Review and Summarization of Utility Qualification Protocols. Preparation, Execute, Review and Summarization of all Process Equipment qualification Protocols  Preparation, Review and Summarization of Sterilization Validation Protocols & Reports Responsible for Preparation, Execute, Review and Summarization of Transport validation.  Responsible for Engineering Assurance and responsible to review Preventive Maintainance, Calibration Checklists, Schedules, Logbooks Preparation of Maintaining of VMP of Equipment qualification and other validations to ensure the completion of activity within due.  Preparation, review and Summarization of the Periodic qualification Protocols and Summary. Preparation , Review and summarization of Miscellaneous study protocols Responsible for ensuring cGMP compliance on working floor and to prepare for all time readiness environments for audit preparation.  Coordination with various departments for commencement of above Qualification activity To involve the investigation of validation related discrepancies and Preparation, Review of investigation report. Handling of CAPAs, Change controls & Unplanned,Planned deviations related to validation. Technical write up as justification/rationale for validation activities for any internal/external audit observations

Plot No: S20 To S24A, Green Industrial Park, Polepally (V), Jadcherla (M), Mahaboobnagar

Sr. Officer - Quality Assurance [IPQA (Production) & Validation (CV, PV, Mediafill, Equipment/Utility qualifications, Transport Validation and Miscallaneous validations)] Line clearance For all Production activities. Line clearance for Dispensing of API and RAW materials. Line clearance during different stages of manufacturing(compounding, filling, visual inspection and washing) In process, finished product, control samples, stability samples and other additional validation or miscellaneous samples collection. Review of Equipments, Area log records. Review of New and Executed BMR and BPR. Online manufacturing process monitoring. Supporting to other departments regarding IPQA related issues. In process checks during all production activities. Review of Batch Production Control Records. Co-coordinating with my IPQA team. Monitoring, execution and review of qualification activities (URS, FAT, SAT, DQ, IQ, OQ, PQ and RQ). Responsible for Preparation, Execute, Review and Summarization of Utility Qualification Protocols. Preparation, Execute, Review and Summarization of all Process Equipment qualification Protocols  Preparation, Execute, Review and Summarization of Automatic Visual/Leak Ingregrated inspection machine qualification Protocols & Reports Preparation, Review and Summarization of Sterilization Validation Protocols & Reports Preparation, review and Summarization of Media Fill validation, Process validation, Cleaning validation/ Verification, Transport validation and Miscallaneous validation. Responsible for Engineering Assurance and responsible to review Preventive Maintainance, Calibration Checklists, Schedules, Logbooks Preparation of Maintaining of VMP of Equipment qualification and other validations to ensure the completion of activity within due.  Preparation, review and Summarization of the Periodic qualification Protocols and Summary.

Plot No.2, Aleap Industrial Estate, Gajularamaram, Hyderabad

Sr. Chemist - Quality Assurance [IPQA (Production)] Line clearance For all Production and packing activities. Line clearance for Dispensing of API and RAW materials. Line clearance during different stages of manufacturing(compounding, filling, visual inspection and washing) In process, finished product, control samples, stability samples and other additional validation or miscellaneous samples collection. Review of Equipments, Area log records. Review of New and Executed BMR and BPR. Online manufacturing process monitoring. Supporting to other departments regarding IPQA related issues. In process checks during all production activities. Review of Batch Production Control Records. Co-coordinating with my IPQA team

Health Care Unit-2, Kolthur, Hyderabad

T.Executive – Production  Responsibe to follow the production plan/schedule  Responsibe monitoring of Dispensing activities  Responsibe to perform and monitor the Batch Compounding & Filtration activities Responsibe to perform and monitor the Leaktest, CIP & SIP activities of Compounding & Filtration activities Responsibe to perform and monitor the Batch Compounding & Filtration activities. Responsibe to perform and monitor the Filling and Half Stoppering activities Responsibe to perform and monitor the Lyophilization activities. Responsibe to perform and monitor the Leaktest, CIP & SIP of Lyophilizer Responsibe to perform and monitor Full Stoppering and Sealing activities. Monitoring of environmental conditions like temperature relative humidity and differential pressure. Area log books updation. Online Documents writing. Co-coordinating with my Production team.

B.Pharmacy, Pharmacy

M.Pharmacy, Pharmaceutics And Drug Design