蔡欣哲蔡

Quality Assurance Associate @ Bora Pharmaceuticals

About

With over five years of experience in the biotechnology and pharmaceutical industries, I have built a professional background across government regulatory affairs, medical device compliance, and pharmaceutical quality assurance. I began my career at the Taipei City Government Department of Health, where I was responsible for matters related to the Pharmaceutical Affairs Act and Medical Devices Act, including regulatory consultation and pharmaceutical inspection procedures. This experience strengthened my understanding of regulatory systems and compliance management. I later joined Rossmax as a Regulatory Affairs Specialist, handling Taiwan medical device registrations and regulatory submissions, including QMS renewals, UDI registration, contract manufacturing applications, and product testing coordination. Through this role, I gained solid experience in medical device regulations and international compliance requirements. Currently, I work as a QA Associate at Bora Pharmaceutical Laboratories, focusing on document control and change control management within the pharmaceutical quality system. My responsibilities include overseeing and optimizing change control workflows, supporting EDMS operations, coordinating cross-functional risk assessments, and ensuring compliance with GxP regulations and internal quality standards. I am also involved in batch record review, product release activities, deviation investigations, and customer audit support. As a passionate and proactive person with the energetic personality of an Aries, I am naturally curious and always eager to challenge myself beyond my comfort zone. I believe continuous learning and adaptability are essential for professional growth in today’s fast-changing industry. With strong communication skills, a positive mindset, and a willingness to embrace challenges, I strive to create value through both compliance excellence and continuous improvement.

Country

Taiwan

City

Hsinchu County

Industry

Pharmaceuticals

Skill

品質系統, change control, Document control, Deviation, SAP ERP, TrackWise, Master Control, 管制藥品管理法, batch record review&release, 醫藥器材法, 法規事務, 醫療器材法規認證, 醫療器材查驗登記

Experience

品質保證

Bora Pharmaceuticals

2023-8 - Present · 3 yrs 2 mos

QA

Bora Pharmaceuticals

2023-8 - Present · 3 yrs 2 mos

竹南鎮

- Manage document control systems to ensure GMP-compliant issuance, revision, distribution, and archiving; serve as QADC for EDMS administration and workflow management. - Oversee GxP document lifecycle (archiving, retrieval, destruction) and ensure traceability and regulatory compliance. - Perform batch record review and execute product release in SAP; maintain master data and drive process improvements by analyzing documentation errors. - Manage change control (CCR), support CCB and APR activities, and ensure timely closure of change requests. - Support internal/external audits (e.g., FDA) and maintain quality system compliance; author and manage deviation reports.

Regulatory Affairs Specialist

優盛醫學科技股份有限公司

2022-10 - 2023-9 · 1 yr

內湖區

- Support ISO 13485 QMS establishment, certification, and maintenance; ensure ongoing compliance and drive audit readiness and continuous improvement. - Monitor global medical device regulations (CE, FDA, ISO, IEC) and perform regulatory intelligence to assess impact and maintain compliance. * Lead Taiwan regulatory submissions, including QMS renewal, UDI registration, contract manufacturing, license applications, and post-approval changes. - Manage post-market surveillance (PMS), including safety reporting, adverse event handling, and risk management activities. - Coordinate product testing (e.g., MDR chemical tests, PFAS, heavy metals) and ensure compliance with regulatory and technical standards.

約僱技士

台北市政府衛生局

2021-9 - 2022-10 · 1 yr 2 mos

台北市信義區

- Conduct inspections, market surveillance, and sampling to ensure compliance with pharmaceutical and medical device regulations; investigate and enforce actions against non-compliant products. - Manage violation cases, including administrative penalties, appeals, and criminal referrals; perform investigations and evidence collection to ensure regulatory compliance. - Plan and execute targeted surveillance programs; analyze testing results to strengthen product quality monitoring systems. - Oversee licensing-related activities, including product recall, destruction, and license transfer processes. - Handle public complaints, conduct investigations, and optimize case management workflows to enhance efficiency and traceability. - Support regulatory programs, including controlled substances self-inspection initiatives across 900+ healthcare institutions