與我們攜手施展你的超能力！  

 

準備好接受挑戰，探索更多可能性嗎? 我們跟你一樣希望精益求精，持續突破! 我們全球的夥伴熱衷於科技創新，透過我們醫藥保健、生命科學和電子科技業務的解決方案豐富人們的生活。讓我們一起環抱著熱情和夢想關懷我們的員工、客戶、病患和這個世界。這就是我們不斷尋找具備好奇心的新血加入的原因，與我們一起大膽想像各種可能。

 

在醫藥健康領域，我們團結一致，齊心為病患，幫助孕育、改善和延長生命。這是我們的目標，也是我們每天不懈努力的原因。默克在腫瘤、神經變性疾病和輔助生殖等領域不斷開發創新藥物、智慧設備與創新科技。我們的團隊遍佈全球六大洲，在共同的理念與好奇心驅動下，我們全力以赴地為處於生命各個階段的患者提供擁抱新生活的機會。加入我們，成為這個多元、包容、靈活工作文化的一份子，並獲得在全球範圍內的個人職業發展機會。

 

The Quality Manager will lead and manage all quality and compliance related aspects for Taiwan with regards to GMP and GDP in alignment with the strategy defined with the business and global quality functions.

Implementing a Quality Management System (QMS) at Healthcare Taiwan.Build quality awareness within local management team and ensure that local management fulfils its role regarding quality requirements as defined in the applicable regulations.Reporting quality performance indicators to local management and take leadership in the performance of Tier 1 Quality Councils and Quality Management Reviews.Establishing and managing an appropriate Quality Department that covers all GMP/GDP quality critical tasks.Implementing Corporate and Global company standards and procedures, international and local applicable GDP regulationsEnsure that the defined quality systems and standards are implemented and followed so that the high-quality standards of the company are achieved.Perform Product Disposition for all shipments received in country. Manage quality related aspects of company GMP/GDP vendors and partners in the country.Liaise with quality global functions (HCQ) and report status of quality systems implementation, KPI and quality issues   

Your Role

The Quality manager is accountable for the quality and GMP/GDP compliance of:

Local QA activities and quality systems in place, and maintained Release for Sale at Subsidiaries, verification of relevant documents to confirm compliance of products received and on time local release for sale to market Product Launch: participation in product launch activities as per relevant global procedure and needs of local subsidiary.Product Returns: assessment of product returns and supporting information to verify if products are suitable for return to saleable status or destruction.Training of local personnel on locally implemented quality systems and GMP/GDP matters (training program, training record)Coordinating product recalls and withdrawal at the local level including investigational medicinal product (IMP) and marketed medicinal productsHandling of GMP/GDP deviations (including receiving, recording, investigating and closing out)Oversee Change Control management for GMP/GDP activities including the implementation of an appropriate action plan Handling and escalation of complaints received from customers (including receiving, recording, investigating and closing out)Implementation and management of quality documents including review and approval of quality documentsCreate internal and external audit plan, program and audit execution by qualified auditors. Manage Health Authority inspections, as part of the audit plan.  Maintain a positive relationship with local health authorities in partnership with local Regulatory AffairsEnsure GMP/GDP critical vendors are qualified (maintaining a master vendor list, establishing Technical Agreements with the vendors, assuring vendors are regularly monitored / followed up)Ensure corrective and preventive actions are defined in a timely manner, documented, tracked and closed in order to improve continuously the quality of the quality processesAct as the local coordinator for Product Alert activities as required To recognise a reportable Adverse Event (AE) or Safety Information and ensure the information is forwarded to the Local Patient Safety Person (LPS) in company, Inc. within 24 hoursEnsure the Adverse Event / Product Complaint reconciliation process is established and maintained. Implement a quality risk management process on the QMS processesAct as a local Quality Learning Coordinator for quality processes

 

        Product Crime officer (PCO):

QA Manager also acts as a local Product Crime Officer. PCO manages product crime incidents in accordance with corporate standards and local regulations for parallel import and counterfeit product.Report suspect product crime incidents to Corporate Security, and other local

stakeholders as appropriate.

Report suspected product crime cases (parallel import and counterfeit product) in the central security database (IRIS) in a timely manner.Support other functions as required (supply chain, regulatory, legal) to ensure suspect

products are assessed/authenticated.

Manage product crime incidents and support resulting investigations as required by corporate security.

Who You Are 

Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field Background in Medicinal product distribution (GDP) highly desirablePreferably at least 5 years' experience related to Pharmaceutical or other related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management or other related activitiesExperience in Good Distribution Practices/Audit as leader auditorKnowledge in local laws and local regulations applicable to the operationProven experience in the area of GMP/GDP and/or quality assurance systems Willingness and enthusiasm to share knowledgeGood time and priority management skills Ability to prioritize and work in a rapidly changing environment.Excellent negotiation and influencing skills, highly desired but not essential Ability to travel nationally and internationally Knowleadge in python, automation, data analytic, highly desired but not essentialDemonstrate fluency in English

 

 

我們來自不同背景、視角與生活經歷，因對世界的好奇心而聚集在一起。我們深信，多元能夠催生卓越與創新，並持續強化我們在科學與技術領域的領導地位。我們致力於為每一個人創造機會，讓大家能依自己的節奏發展與成長。加入我們，一同打造一個充滿包容與歸屬感的文化，影響數百萬人的生活，攜手推動人類的進步！

 

立即申請，成為這個致力於激發探索精神、提升人類未來的團隊一員！