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

Requirements:

• 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

LANGUAGES:

• Fluent English (full proficiency)

Full-Time Job