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CSV Engineer

  • Job reference: 925956
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 12/06/2019

Orion Group is recruiting a CSV Engineer on behalf of our Multinational Biotechnology Client based in Dun Laoghaire for a 6-month contract initially

Requirements:

  • Computer Systems Validation, Quality Management, Quality Assurance (circa 2-5 years experience)
    * Ideally some GxP Applications CSV (Protocol and SOP writing experience is a MUST)
    * Infrastructure Quality Management
    * Project Quality Management
    * Compliance Assessment, FMEA, Risk Assessment including GxP Training and Coaching of CSV activities
    Periodic reviews for SOPs, review documentation (this is ill be the main focus)

    * HP ALM review and approval of testing Creation of plans, protocols and reports
    * Knowledge of GxP, 21 CFR Part 11 and other industry relevant.

    The requirement is for 6 months to support compliance and periodic reviews of the documents in IS department.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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