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

TS Validation Specialist

  • 全職

Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
Your knowledge of the manufacturing domain will help in understanding of process equipment and systems, manufacturing operations, and automation control. Your primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations. You will assist with production planning and provide / support coordinating production activities, working with the Clinical Manufacturing Team Leads and Process Engineers. You will provide training for operational qualifications and assist the Team Lead and Process Engineer in assuring all personnel are appropriately trained for the applicable tasks. You will provide process execution and equipment operational activities in support of cGMP (current Good Manufacturing Practices) and /or commercial manufacturing. You will advise management of non-conformance issues and opportunities for continuous improvement. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to completion of project milestones and organize own work to meet project task deadlines. Assess challenges to the schedule and re-directing activities as necessary to minimize impact to quality, compliance and timelines. Capable of detecting technical problems and assisting the appropriate colleagues for resolution. Perform routine equipment qualification and validation tasks such as preparing documentation, materials, coordinating resources from cross-functional team for equipment e.g. washer, autoclave and dehydrogenation oven, lyophilizers and tank... etc.
Able to collect and assemble applicable, vital information for recommendations to Production Supervisors and/or Manufacturing Process Engineers to assist in troubleshooting and decision making. Organize daily functions and work in concert with Production, Engineering, Quality... Technicians in executing operational aspects for different processing in a compliant, safe and efficient manner to maintain production schedules.
Understand scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements. Develop best practices and share with other teams and sites. Conduct all activities that are in accordance with company policies and Standard Operating Procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines, as appropriate, etc. Provide input and revise Standard Operating Procedures, batch records, forms or other {Current} Good Manufacturing Practices {part of GxP} related documents to support continuous improvement efforts, investigation corrective actions etc. Track and follow-up on departmental commitments, investigations, change controls, change control and general compliance initiatives.

工作條件

  • 接受身份: 上班族
  • 工作經歷: 不拘
  • 學歷要求: 大學
  • 語文條件: 英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等
    中文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Qualifications

    Must-Have

    Minimum of Bachelor degree in science or engineer (Chemical, Industrial or Mechanical), or related science.
    Demonstrated experience within the pharmaceutical industry, including knowledge and experience with relevant unit operations and/or laboratory operations
    Proactive in engagement with key stakeholders
    Basic English ability and interpersonal skills
    Verbal and written communication skills
    Ability to efficiently use current computer packages including Excel, PowerPoint, MS Project and Word
    Nice-to-Have

    cGMP plus validation and/or manufacturing experience
    Knowledge of operational aspects for aseptic processing

福利制度

1. 業務同仁獎勵辦法 / 績效獎金制度
2. 員工旅遊
3. 主管與業務同仁汽車提供辦法
4. 週休二日
5. 勞工保險
6. 國定假日及年假制度
7. 全民健康保險
8. 退休制度
9. 團體保險
10.同仁在職進修補助
11.年度健檢
12.員工子女獎學金
13.社團活動
14.中秋、端午、春節三節禮金

更新日期:2021-08-24

應徵方式

  • 職務聯絡人: HR
  • 聯絡E-Mail: 未填寫 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33%
1~3年0%
3~5年0%
5~10年33%
10年以上33%
學歷分佈
碩士及以上67%
大學33%
專科0%
高中0%
高中以下0%
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