求人情報検索

CSV Consultant

PQE Group SRL

PQE Group SRL

求人ID
124607
勤務地
大阪府 Osaka
掲載日
2017年12月21日
業種
サービス業
職種
ITコンサルタント
雇用形態
正社員 / 新卒・第二新卒
給料
給与についての記載なし

応募条件

  • 日本語: 流暢
  • 英語: 流暢
  • 2+ years of Computer System Validation experience or any validation experience required
  • Past experience writing, reviewing and executing computer validation documentation
  • I am fluent in Japanese and can explain technical concepts in Japanese

説明

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide.
An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.

Due to a constant growth, PQE is looking for a new CSV Consultant.

Responsibilities:
- Resolution of fundamental CSV compliance issues
- Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
- Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
- Ensure completeness and consistency of project life cycle documentation
- Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
- Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
- Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP

Requirements:
- 2+ years of Computer System Validation experience or any validation experience required
- Past experience writing, reviewing and executing computer validation documentation
- Excellent communication skills
- Ability to work as a team player in a consulting environment
- Proactive approach
- Results oriented
- Full availability to travel domestically
- Proficiency with MS Office tools
- Documentation management

この情報は一般的な求人情報であり、ジョブオファー及び契約を結ぶものではありません。

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