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.
Due to a constant growth, PQE is looking for a new Validation Consultant for our Osaka team.
Responsibilities include, but are not limited to, the following:
- 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 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
- 2+ years of Computer System Validation experience or any validation experience required
- Past experience writing, reviewing and executing computer validation documentation
- Excellent communication skills
- Ability to work as a team player in a consulting environment
- Proactive approach
- Results oriented
- Full availability to travel domestically
- Proficiency with MS Office tools
- Documentation management
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.