job location Job Location:

San Antonio (TX), U.S.A.

 

Computer System Validation Consultant

Requested Languages:

English
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job at pqe

PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.

PQE is looking for a new Computer System Validation Consultant willing to join our US team.



    MAIN 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:
  • 3-7 years of Computer System Validation
  • Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
  • English language proficiency
  • Valid US work permit
  • 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
  • Full availability to travel (up to 70%) across the US Area

Full-Time Job

If interested, please apply clicking the button on 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