수평: Mid-Senior level

직업 종류: Full-time

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작업 내용

Job Description

Job title: Project coordination for archiving and migration project

Context:

· Our client is well advanced in its digital transformation, hence legacy applications must be archived, prior to being decommissioned.

· Our client has recently acquired a company. The integration phase has started. Quality and Regulatory Affairs legacy data & documents are to be transferred into our client’s systems & processes.

· Legacy systems are to be timely decommissioned.

Role:

· Be part of the IT Regulatory & quality team as coordinator for the integration of the newly acquired company into our client’s processes & systems, in close collaboration with Regulatory Affairs and Quality colleagues.

· The context is a pharma company in a GxP environment.

· Manage different deliverables throughout the project (from requirements to validation documents) in a GxP environment:

- Manage, review & approve GxP validation documents

- Coordination of the test matrix, ensuring execution, documentation, and fixing defects

· Oversee all aspects of projects: responsible for planning, follow-up, and overseeing activities to ensure timely completion within budget

· Coordinate with internal teams and external partners for the flawless execution of activities

· Report and escalate to stakeholders as needed

· Manage the relationship and communication with all stakeholders involved.

Experience:

Mandatory:

· Interest in Archiving topics & compliance with regulations

· Interest in data like a business analyst: try to understand & share how things work with the end result in mind.

· Data integrity understanding and compliance

· Working knowledge of Computer System Validation

· Passion, dedication, end-to-end results-oriented: the end results count.

· Project coordination capable & technology-oriented with a minimum 2 years pharmaceutical/biopharmaceutical experience

· Strong working knowledge of Microsoft Office in particular MS Excel and MS Project

· Working knowledge of Planisware which is our client’s project management & scheduling tool is a plus

· Knowledge of core QMS processes in a GxP (bio)pharma environment

· Fluent in English: French is a plus

· Solid organizational skills including attention to detail and comfortable managing multiple projects and tasks.

· A detail-oriented approach to deliverables. Focus on quality in your day-to-day work

· Autonomous and energized

· A team player and a problem-solving aptitude.

· Strong interpersonal, verbal, and written communication skills as there is a high degree of collaboration required mainly with different members of Global QA, IT Compliance as well as other IT or Business functions

Nice to have:

· Knowledge of Veeva Life Sciences, Trackwise, Analytics with e.g. Cognos, QlikSense are a plus

· Project Management Professional (PMP) / PRINCE II certification is a plus

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마감 시간: 31-12-2025

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