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.
Further information can be found at www.pqegroup.com or visit our company page on LinkedIn https://www.linkedin.com/company/84095/.
Due to a constant growth, PQE is looking for a new Computer System Validation Expert.
* 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 6 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 internationally: up to 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
Location: Warsaw, Poland