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job location Job Location:

Raleigh - NC, USA

 

CSV Consultant

Requested Languages:

English
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job at pqe

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 600 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 Computer System Validation Consultant based in Raleigh (NC), available to join one of our CSV projects in the Raleigh area.



    RESPONSIBILITIES:
  • Resolution of fundamental Computer System Validation (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 project team complies with the methodology and SOP and uses the correct tools
  • 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:
  • 2-3 years of Computer System Validation (laboratory equipment validation experience as a plus)
  • Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
  • English language proficiency
  • Excellent communication skills
  • Ability to work as a team player in a consulting environment
  • Able to manage direct relation with stakeholders and project team members
  • Proactive approach
  • Results driven oriented
  • Valid US work authorization

If interested, please send your resume clicking the button on the left of this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe