System/Equipment Validation Consultant
- Lieu : Region of Antwerp
- Type de contrat : Contrat à durée indeterminée
- Débute le : 08 janvier 2020
Descriptif de fonction
Supports the project leader in coordinating the project team to achieve the defined project deliverables in relation to validation:
- Lists together with the project leader and project engineers which validation activities need to take place and in what sequence.
- Clarifies the overall project validation strategy to the entire project team.
- Provides a continuous overview of the status of all validation activities and advises the project leader in relation to impact on project timeline.
- Continuously follows up the predefined validation strategy and adjusts / escalates if needed.
Writes and manages the VPP/VPR together with the project lead.
- Watches over good validation practices (verification, validation master plan, change management, …) and the quality of the different deliverables.
- Facilitates general validation activities (system risk assessment, cGMP-review). Point of contact related to validation in the project.
- Coaches the project engineers related to verification/validation/CRF/QRM in the project.
- Bridges between Engineering, Site Compliance, SME, System Owner throughout the project.
- Clarifies the overall project validation strategy during internal and external project audits.
Supports the project leader in coordinating the project team to achieve the defined project time line:
- Assist the project lead to compose, consolidate and update a timeline with different milestones, which must be endorsed by the team.
- Develop and maintain accurate and complete detailed project schedule file in MS Project. Monitor continuously the project schedule file for integrity and completeness.
- Keep the project team informed regarding the progress of all project tasks and activities and provide input for the management communication & reporting.
- Alert the project team and Project Management of problems/conflicts relating to the execution of project tasks and activities.
- Assist the project lead to define and evaluate project risks and to propose a mitigation plan. Document this process in the Project Risk Management document.
- good communication skills
- quality mindset
- detail oriented
- planning skills
Not looking for a technical profile but (for example) a person coming from quality with validation documents experience
- Minimum 3-5 years’ experience in similar position (Validation in Engineering environmental, not labo)
- Bachelor or equal by experience
- Experience as a team member within projects.
- Risk assessments, establish schedules/planning’s, project coordination experience
- Dutch mandatory (spoken and written)
We are Not looking for computer validation, QC validation, method validation, cleaning validation, product validation, component validation. But System/Equipment Validation.
Evolia is continuously growing and tends to hire highly motivated professionals in order to cover more geographical and industrial fields.
You will receive a permanent contract with competitive salary supplemented with attractive fringe benefits such as communication allowance, representation allowance, mobile, internet@home, hospitalization and group insurances.
20 holidays and 12 compensatory days an access to continuous training.