黃飛凡 Email & Phone Number

Have over 3 years of experience as a quality assurance specialist in pre-clinical testing industry(CRO). In addition maintaining quality systems, also have undergone multiple official and client audits, familiarizing myself with GLP and cGMP quality concepts and other regulations, consistently achieving the company's quality objectives and certifications.Experienced multiple customer audit situations, demonstrating fluent responses and earning customer recognition and confidence in the quality system.Career Highlights1. Underwent a total of 6 official audits domestically and internationally, all resulting without major deficiencies, instilling confidence in quality system management.2. Received GLP qualification extensions and routine supervisory audits from TAF and TFDA in 2021, 2022, and 2023, with no major deficiencies reported in any of the three years. Completed internal improvement operations and responded to reports within three months of receiving audit reports.3. Underwent an initial FDA inspection for customer product applications in 2022 and a routine surveillance inspection in 2023, with no significant findings (no OAI finding was found), marking a milestone in the company's quality management.4.Received a GMP audit from EU QP in 2023, with no significant findings. Obtained GMP certification issued by EU QP in November of the same year, establishing the company's GMP quality concept as internationally recognized.5. Successfully handled the increasing standards of quality and technical SOPs within the company, ensuring timely completion of regular reviews, implementation, and training. The task of document management has provided me with an in-depth understanding of internal procedures, laying a solid foundation for both internal and external audits in the future.

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  長庚大學

  Biomedical