求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Established Pharmaceuticals - Assistant Quality Assurance Manager

  • 全職

• Implement and manage quality systems and training programs as necessary to support CAPA, validation, complaint registration, physician sample handling, inspection reporting and tracking, policy implementation, supplier management, document and change control management, distribution and material control at the local commercial EPD.
• Develop and maintain Commercial Quality Management System Manual while minimizing cost increases and potential disruptions to business. Ensure the implementation and maintenance of activities related to compliance to policies, processes, procedures and plans that define these elements necessary to meet the Quality objectives, along with Regulatory and business requirements
• Represent the Commercial Affiliate on Cross-Region teams, projects or issues as required
• Interpret and evaluate local market regulatory requirements and standards
• Provide integrated QA support in QA related issues for EPD Supply Chain
• Provide support to local outsourcing activities and product launches through management of the First Lot Quality Review program
• Assure that quality related issues associated with products distributed / products distributed conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards in order to assure readily available supply of compliant, authentic, safe and efficacious products at market competitive cost
• Initiation, periodic review and revision of the local quality documents (e.g., Affiliate Site Master File, QA SOPs/Forms/Templates) to maintain Good Documentation Practice continuously.

工作條件

  • 接受身份: 上班族
  • 工作經歷: 五年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: • College or University degree required, technical (life Sciences) or business-related discipline. Pharmacist is preferred.
    • At least 5 years’ QA experience in Pharmaceutical or medical device (or related industry) QA/Regulatory
    • 2-3 years’ experience with management of complex projects or programs
    Adaptability, Initiative, Integrity
    • Planning and Organizing
    • Ability to prioritize
    • Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making
    • Project management and troubleshooting skills
    • Fluent in English. Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds
    • Knowledge of local regulations for quality systems and compliance
    • Ability to identify problems, and initiate corrective actions and preventative actions
    • Sound decision-making skills contributing to high levels of competence, confidence and credibility are required
    • Well-developed interpersonal, communication and negotiation skills
    • Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
    • Change management
    • Experience in or working with regulatory organizations

福利制度

工作時間
。每週工作五天,四十小時,提供彈性上下班辦法。
休假制度
。各種休請假符合或優於勞基法規定。
薪資制度
。基本薪資每年依市場變動調整架構,最具市場競爭性 。
。薪資依績效調整,良好表現者得到相對的獎勵。
。每年固定年終獎金,依職別另有不同的績效獎酬計劃 。
福利制度
。勞工保險、全民健保、新制勞退金提撥。
。員工及眷屬團體保險(壽險、意外險、醫療住院保險、癌症險、重大疾病險)。
。退休暨離職金辦法。
。三節年節禮金。
。員工旅遊及活動補助,婚喪喜慶及生育禮金。
。年度健康檢查。
。資深員工服務獎勵。
。員工協助方案。
。公司產品員購折扣。
。員工優惠購股計劃。
。職工福利委員會。
。克勞拉亞培基金會: 全球亞培員工專享的生活服務資源,專門協助所有現職及退休員工有關子女教育獎學金申請及財務紓困計劃。
訓練制度
。系統性業務人員業務推廣訓練核心課程。
。各種職能、績效管理、主管發展訓練核心課程及外語訓練辦法。主要以在職訓練,從工作中學習為主軸。
。由專業訓練經理規劃訓練體系,公司並培訓內部講師群執行核心課程。主管及行銷企劃人員可輔以亞培海外訓練體系。

更新日期:2021-10-20

應徵方式

  • 職務聯絡人: 人力資源部
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年20%
5~10年0%
10年以上80%
學歷分佈
碩士及以上40%
大學60%
專科0%
高中0%
高中以下0%
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