CSV Consultant (expired)

PQE Group SRL

Company

PQE Group SRL

Job ID

124607

Location

Osaka, Osaka, Japan

Post date

Dec 21, 2017

Industry

Service Industry

Function

IT Consultant

Work Type

Full Time / Entry Level

Salary

Amount not specified

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.

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

Responsibilities:
- 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

Requirements:
- 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