Date added

17.04.19

QA经理 QA Manager

  • Department: Quality & ESH
  • Hours: Full-time
  • Location: Shanghai, China
  • 工作内容及职责/Job Description:

    1. Prepare / Review release documentation for raw materials, intermediate and finished product.
    2. Provide QA oversight for deviations, OOS, Change Control.
    3. Support internal and external audit, assisting in the preparation and smooth execution of audits from Health Authorities, Corporate, Customer.
    4. Support reporting and trending of Quality KPIs on periodic basis as required.
    5. Identify and lead continuous improvements initiatives, including workflow processes to improve productivity.
    6. Review the SOPs, specifications, method of analysis, batch records and other technical document.
    7. Provide QA oversight for utility systems, production equipment, warehouse (including raw materials, packaging materials and recovered solvents)
    8. Assist Head of Quality Unit in any other duty as required.

    专业知识及技能/Knowledge and Skill:

    1) Minimum 5 years working experience in quality department with good understanding of quality requirements (e.g. FDA, cFDA, EMA, MHRA) and production processes. Working experience in a GMP environment in pharmaceutical/API industry.
    2) Fast learner with ability to adapt to changes, and with continuous improvement mindset. Able to write and communicate well in English (intermediate level) and in Chinese language.

  • About CARBOGEN AMCIS:

    CARBOGEN AMCIS AG ist ein führendes Dienstleistungsunternehmen im Bereich der Produkt- und Verfahrensentwicklung bis hin zur kommerziellen Produktion von Wirkstoffen für die pharmazeutische und bio-pharmazeutische Industrie mit Schweizer Standorten in Bubendorf, Aarau, Hunzenschwil und Vionnaz sowie den Standorten Riom (FR), Manchester (UK), Shanghai (CHN) und Veenendaal (NL). Unser unternehmerischer Erfolg basiert auf der hohen fachlichen und persönlichen Kompetenz unserer Mitarbeiterinnen und Mitarbeiter.

  • How to apply

    Please complete the form with the relevant details and apply using the button below.

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    Alternatively, please send your C.V. & cover letter detailing the job reference, to:
    CARBOGEN AMCIS (Shanghai) Co., Ltd.
    No. 69 Shungong Road
    Shanghai Chemical Industry Park
    Shanghai 201507
    China
    Tel. +86 21 6712 1166

How to apply

Please complete the form with the relevant details and apply using the button below.

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C.V. / Resumé
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Cover Letter
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Diplomas
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Alternatively, please send your C.V. & cover letter detailing the job reference, to:
CARBOGEN AMCIS (Shanghai) Co., Ltd.
No. 69 Shungong Road
Shanghai Chemical Industry Park
Shanghai 201507
China
Tel. +86 21 6712 1166