Job Location:
Milan, Italy
CSV Consultant

Due to a constant growth, PQE is looking for a new CSV Consultant.
- 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
In this fulltime position, responsibilities include, but are not limited, to the followings:
- 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%
Requirements:
- Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus
- Proficiency with MS Office tools
- Documentation management
Nice to have:
- Fluent English (full proficiency)
LANGUAGES:
Full-Time Job
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