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Milan, Italy


CSV Consultant

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job at pqe

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

    In this fulltime position, responsibilities include, but are not limited, to the followings:
  • 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 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
  • At least 2+ years of Computer System Validation or any validation experience required
  • Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
  • 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
  • Full availability to travel domestically and abroad: up to 50-75%
    Nice to have:
  • Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus
  • Proficiency with MS Office tools
  • Documentation management
  • Fluent English (full proficiency)

Full-Time Job

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