Senior Corporate Quality Auditor

Posté 01 août 2022

Taipei, T'ai-pei - Taiwan

Demander un identifiant 253675

Détails

在我們企業的職業生涯是一段不斷探索的旅程:我們約 60,300 名員工正透過新一代的先進醫療保健、生命科學與電子科技,塑造全球的生活、工作和娛樂方式。350 多年的歷史與遍及全球的軌跡,我們熱切地推動我們的好奇心,以便找到創新和充滿活力的方式來改善他人的生活。

我們在電子科技領域裡所做的一切,都是為了能成為眾多企業身後推動數位化生活的推手。我們致力於成為值得信賴的供應商,為電子、汽車和化妝品行業提供高科技材料、服務和特種化學品。我們培養了一個全球協作的組織,每位員工都擁有取勝的熱情、秉持客戶至上的態度、充滿好奇心且行事果決。我們齊心努力突破科學的極限,為客戶創造更多的可能性。

 


PURPOSE OF THE ROLE

  • Assess the level of quality and compliance of suppliers in APAC/Greater China Region vs. applicable contractual agreements, company standards, regulatory requirements and business needs
  • Assess the level of quality and compliance of company site QMS on assigned internal audit program
  • Identify and alert the Corporate Management of business threats and risks
  • Support the stakeholders with risks management and CAPA plan establishment
  • Support the maintenance of the SQQA workflow / eSQA system improvement and network based in APAC/China to manage the suppliers

MAIN TASKS & RESPONSIBILITIES

  • Timely schedule and execute audits as per approved SQ-QA Audit plan
  • Deliver audit findings to auditee’s management in a constructive yet firm manner
  • Report in timely manner reliable assessment of the applicable ISO/GxP/ company quality requirement compliance level of processes, tools, quality systems, and resources of suppliers
  • Report in timely manner reliable assessment of the applicable ISO/GxP/ company quality standards compliance level of processes, tools, quality systems, and resources of company organizations according to internal audit plan
  • Issue reports in English according to the established SQ-QA standard
  • Alert immediately the Management of any critical or compromising audit finding in an expert manner
  • Support the stakeholder in the establishment of a technically sound CAPA plan, and to follow up on CAPA until completion and close-out of the audit
  • Produce reports on quality/trends/indicators on the basis of audit findings
  • Support the establishment and maintenance of compliant and efficient audit processes within SQ-QA

MANAGEMENT SUPPORT

  • Support the Management in completing the audit program
  • Participate and/or lead in the elaboration and generation of audit tools (e.g. templates, checklists, SOPs, working instructions)
  • Provide support in the field of technical expertise to other SQ-QA functions to achieve the departmental objectives

FUNCTIONAL KNOWLEDGE

  • Solid knowledge and experience of internal Quality Standards, and rules and regulation including but not limited to: Chinese GMP, EU GMP, US GMP, ICH Q7, WHO, GDP, ISO9001 as a must and an IATF16949 Lead auditor certification is an asset
  • Knowledge and experience in the manufacturing of Electronics chemicals, Raw materials/chemicals, Pharmaceutical Drug Substances chemistry and/or pharmaceutical Drug Products forms, Storage / distribution and release of products
  • Ability in identifying risks to quality and business during auditing activities and to evaluate their magnitude and potential impact.
  • Current with the international quality and regulatory Standards, trends, rules and regulations

EDUCATION AND LANGUAGE

  • Life Science degree, Chemistry, Chemical Engineering, a Master or a PhD would be a plus
  • Chinese mother tone; Fluency in English is a must

PROFESSIONAL SKILLS & EXPERIENCE

  • Minimum 10 years solid experience in Electronics materials, Pharmaceutical materials, intermediates (Excipient, API, Food, Cosmetics etc.), manufacturing of pharmaceutical products.
  • A minimum of 5 years in auditing
  • Solid Quality Assurance understanding and experience in an Electronics or Life Science or regulated HealthCare environment is a must
  • Demonstrated success records in independent auditing
  • Solid management experience of Supplier Quality management function is a plus
  • Assertiveness and strong skills: ability to interact constructively with management and functions

我們提供:我們充滿好奇心的團隊是由多元的背景、觀點和生活經驗所組成。
我們宣揚多元的各個面向。我們相信,就是這樣的多元推動了卓越、創新和人類進步。我們關心我們的客戶、患者和各式各樣的人們。這種多元強化了我們在科技領域中的領導能力。
我們致力於為所有人創造機會,並賦能實現妳的誌向。我們的各大事業單位提供了各種職涯發展機會並拓展妳的視野。
加入我們壹起打造可影響數百萬人的包容性和歸屬感文化,讓每個人都能將自己的好奇心實現成真!

 

妳好奇了嗎?歡迎透過以下連結申請並瞭解更多資訊 https://jobs.vibrantm.com
如果妳希望瞭解更多關於多元、平等和包容性對我們的意義,請參訪 https://www.merckgroup.com/en/company/press-positions.html

 

Postuler