Rike Yulianingtyas Nauri Putrie

Experience

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  SUSTAINABLE DEVELOPMENT SOLUTIONS NETWORK (SDSN)

  Oct 2016 - Oct 2016

  Participant

  Participant of TOP 40 YOUTH DIALOGUE STUDIO SUSTAINABLE DEVELOPMENT SOLUTIONS NETWORK (SDSN) 2016” Theme: “ What We Talk About When We Talk About Climate Change ” at Auditorium Microsoft Indonesia Jakarta Stock Exchange Building Tower II SCBD, October 2016

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  International Indonesian Scholars Association

  Nov 2016 - Dec 2016

  Supporting team

  Project:Supporting Team I-4 (Ikatan Ilmuwan Indonesia International) International Indonesian Scholars Association “ Visiting World Class Professor ” at Ministry of Research and Technology Dikti Jakarta, December 2016

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  Ic Thusi

  Nov 2016 - Nov 2016

  Participant

  Participant of “ The Third International Conference Human Sciences: Theory and Practice In Islamic Prespective ” Ic-Thusi at Gedung Nusantara V DPR/MPR RI dan BPPT-Jakarta, November 2016

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  Universitas Pancasila

  Feb 2017 - Feb 2018

  Pharmacist
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  Gerakan Nasional 1000 Startup Digital

  Apr 2017 - Apr 2017

  Participant

  Participant of “ Gerakan Nasional 1000 Startup Digital ” at Ministry of Communications Jakarta, April 2017

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  Suku dinas kesehatan jakarta selatan

  Aug 2017 - Aug 2017

  Internship
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  ETHICA INDUSTRI FARMASI, PT

  Sept 2017 - Oct 2017

  Internship

  Internship at Quality Assurance Compliance and Quality Management System Departement

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  Conference On Indonesia Foreign Policy (CIFP)

  Oct 2017 - Oct 2017

  Participant

  Participant of “ Conference On Indonesia Foreign Policy (CIFP) ” In order to ASEAN 50 “ at The Kasablanka Jakarta, October 2017

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  Apotek Farmarin VII Bekasi

  Nov 2017 - Nov 2017

  Internship
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  PT ETHICA INDUSTRI FARMASI JOINT VENTURE WITH FRESENIUS KABI

  Apr 2018 - Aug 2020

  Compliance & Project Quality Control

  (2018-2020) main responsibility : 1. Responsible for conducting sterililty test with closed system membrane method validation project (to prepare protocol, ensure testing, review and reporting the result)2. Responsible for conducting bacterial endotoxin test (BET) with gel clot method validation project (to prepare protocol, ensure testing, review and reporting the result)3. Responsible to assist and support microbiology studies4. Support for development and improvement of laboratory processes and systems. Support continuous improvement activities and also relayout of microbiology laboratory project.5. Assist in laboratory investigation such as of deviation (OOS) results from routine samples as well as sterililty failure and also another microbiology testing. 6. Ensure compliance to Good Manufacturing Practice and Good Laboratory Practice well applied in daily laboratory activity.7. Support and handling for CAPA, Change control, and deviation related GMP management and monitoring.8. Develop and revise of SOP for new and establish process, materials, products, and systems based on global and local requirements.9. Responsible for GMP and GLP training regarding with microbiology.10. Reporting of Gap Assessment related on global and local procedure.11. Create of user requirement specifications (URS).12. Support for performance qualification (PQ) for new technology in microbiology Lab.13. Support for external audit regarding with material supplies for microbiology and external Lab.14. Ensure materials and calibration status of instruments in microbiology Lab.15. Support for self inspection program/internal audit activities for GMP aspect.(2020) additional :1. Arrange and make sure that every testing is conducted based on SOP and requirements.2. Managing time analysis and arrange the schedule of testing weekly based on analyst qualification.3. Reviewing the results of microbiology testing. Show less

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  PT. Meccaya Pharmaceutical

  Aug 2020 - now

  QC Assistant Manager

  1. Planning, managing and ensuring daily QC Analysis (Raw Material, Packaging Material, Finish Product, Stability, and Microbiology) are in accordance with procedures, requirements, and achieve the target.2. Handling of Validation and Verification of analytical method, Computerized system validation, and also Study of analytical methods.3. Handling of CAPA, OOS, Change Control, and Training in QC.4. Support for Audits (internal & external). 5. Reporting monthly QC target.6. Developing and revise SOP/Specification/Procedure analysis methods based on requirement/compendial. 7. Identify and investigate quality control issues, recommending solutions to improve product quality.8. Responsible for the development and training of QC teams by conducting internal/external training.9. Create an annual budget for the QC Department, and break down the budget in quartal periods.10. Ensure compliance in QC related to regulations (i.e., CPOB, CPKB, ISO, Indonesia Ministry of Health, etc).As an QC assistant manager who is always open minded to providing suggestions and input to improvement for QC.Skill: Communication, analytical thinking, problem solving, managing team and leadership. Show less