Vivien Peng

Experience

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  North China Pharmaceutical Huasheng Co., Ltd

  Jul 2004 - Jun 2005

  Intern

  -Serve as QA auditor for the process of drying and, aseptic filling and packing of company products-Internship in Chemistry, Microbiology and Instrumentation Departments of Quality Control Unit-Independently operate and maintain HPLC and GC-Develop method for one antibiotic product according to USP, and draft relevant SOPs-Develop method for testing the raw material of industry-grade acetone, and draft relevant SOPs-Get trained of analytical method validations

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  North China Pharmaceutical Huasheng Co.,Ltd

  Jul 2005 - Aug 2006

  International Registration Officer

  -Translate over 100 batch documents (from Chinese to English)-Independently draft the drug file for one API product to be registered in Russia -Responsible for preparation of Manufacture, Characterization and Control of Drug Substance part of CTD files-Write minutes during FDA inspection-Respond to questionnaires from customers

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  Beijing Canny Consulting & Service Company

  Aug 2006 - Feb 2007

  Consultant

  -Translate over 100 SOPs, DMFs and SMPs-Provide consulting services and conduct site inspection at API production company for FDA GMP compliance-Serve as the technical translator in the USP verification forum

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  Bridge Laboratories

  Apr 2007 - Oct 2009

  QA Auditor

  -Provide training for new QA personnel on method validation/toxicology study audit-Provide basic GLP training for new hires-Perform annual review QAU SOPs-Serve as QA representative on FDA Readiness Working Group and assist in the FDA readiness training sessions-Provide assistance in FDA inspection-Plan independently QA inspection schedule-Conduct inspection on critical phases of toxicology studies and method validation projects-Conduct audit on study raw data (paper-based and electronic data), protocols and reports-Conduct facility inspections (facility, equipment, process etc) and provide recommendations to QA management for quality system improvement-Report deviations and/or findings to study director and management and review Study Director’s Response Form to ensure if appropriate corrective actions are taken-Maintain master schedule-Update and maintain QA audit log-Audit GLP study data/report and critical phases under the supervision of QA management-File and maintain QA inspection records and submit for archive upon study completion-Serve as internal project manager within the QA department-Distribute and maintain copies of SOPs-Translate SOPs from English to Chinese-Keep and manage personnel files (resume, job description, and training records)-Organize meetings and write meeting minutes Show less

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  Charles River Laboratories

  Oct 2009 - Apr 2010

  Senior QA Auditor

  -Conduct QA inspection on studies and facility-Suggest corrective actions to top management and study directors based on the independent judgment-Coordination of government and customer audits-Management of QA internal projects-Conduct GLP training and inspection readiness training

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  Beijing Cord Blood Bank

  May 2010 - Jun 2017

  -Quality Assurance:-Quality Control:-Team Management -Assist QA manager establish and maintain the quality system for regulation, ISO standards and AABB standards compliance-Establish SOPs management system-Coordinate the government inspection, ISO inspection and AABB audit-Conduct QA inspection and internal audit-Deviation management, including root cause analysis, corrective action identification and follow up-Training staff for quality system, SOPs management, records management, deviation and external inspection readiness

  • Manager, QA

    Apr 2013 - Jun 2017

  • QA Supervisor

    May 2010 - Mar 2013
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  Q SQUARED SOLUTIONS CHINA LIMITED

  Jul 2017 - Oct 2019

  Senior QA Auditor

  - Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts. Audits are conducted to assess compliance with applicable regulations / guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.- Prepare and review and approve corrective action plans.- Present educational programs and provide guidance to operational staff on compliance procedures.- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.- Host customer audits.- Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.- Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.- May perform GLP Archivist duties where needed.- Assist in training of new Quality Assurance staff. Show less

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  Beijing Cord Blood Bank

  Nov 2019 - Jun 2021

  Manager, QA

  - Quality Assurance: Assist Top management make the quality objectives and monitor achievements in each department Establish and maintain the quality system for regulation, ISO standards and AABB standards compliance Conduct QA review of SOPs and forms SOPs management Conduct internal audit Host the government inspection, ISO inspection and AABB inspection Deviation/non-compliance management Review process development/change plans, validation protocols and reports, to ensure the effectiveness and controllability of the technical process Assist top management conduct management review, draft management review report and suggest on the quality improvement in the coming year Respond to the questions on regulations and standards compliance from each department Quality culture establishment throughout the company- Quality Control: Conduct inspection on critical incoming materials Monitor external PT results to identify the needs for corrective actions Product stability test Monitor lab environment Calibrate, verify, test lab equipment functions Analyze lab quality data to identify the needs for corrective actions- Team Management: QA team management, responsibilities assignment and competency assessment Training of QA staff for continuously fulfillment of job responsibility and maintenance of competency Show less

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  GoBroad Central Lab Co., LTD

  Jul 2021 - now

  AD, QA

  - Ensure the establishment of quality system for central lab and bioanalytical lab- Host customer audit and regulatory inspection- Ensure the implementation of internal audit and project audit- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures- Manage quality issues and customer complaints- Ensure the implementation of vendor audit- Ensure the establishment of QA procedures- Present educational programs and provide guidance to operational staff on compliance procedures- Ensure the implementation of SOP management- QA team management and training Show less