Pauwels Consulting
Pauwels Consulting, with head offices in Diegem and Ghent, is a fast-growing, independant and dynamic company with more than 100 employees. For over ten years Pauwels Consulting has been a loyal partner with expertise in IT, Engineering and Pharma for plenty of clients in Belgium, the Netherlands, Germany and France. In IT we offer global solutions with new technologies for application and web development, Business Intelligence and data warehouse. Our network and system engineers support our clients with our infrastructure services, helpdesk and support in different operating systems. In Engineering Pauwels Consulting is the number one partner for large (petro)chemical, industrial and production companies in Belgium and the Netherlands. We offer solutions for design, process, construction and supervision of specific projects. The consultants in our business unit Engineering Services can always be hired for solid support to industrial projects. Pauwels Consulting is also the perfect Pharma partner, not just for pharmaceutical and biotech companies, but also for their suppliers. Our consultants validate computer systems, processes, lab equipment and other specific applications. Our experts also provide on site quality control, audits and analysis, and GMP training and coaching and even product support. If so desired, we can set up projects from a to z (Special Projects). Pauwels Consulting’s strength lies in our consultants. Pauwels’ consultants are flexible and enthusiastic high potentials, and we are very happy to put our experience and expertise to work for the success of our clients.
QA Qualification Engineer IT
Description de la fonction
Project Description
A new warehouse building in Hainaut will be the Distribution Centre in an European Distribution Network for 11 countries. From a qualification and validation point of view the project includes the following aspects:
• Facilities: ambient and cold storage location (design, construction, commissioning)
• Equipment and related operational processes
• Environmental systems,
• IT systems: Warehouse Control and Warehouse Management Systems
• Shipping routings in the distribution network
Job Description
• Set up the project qualification strategy, based on specific procedures.
• Active involvement in the writing of the following qualification documents
o Project Qualification Plan (PQP)
o User Requirement Specifications (URS)
o Impact assessment (IA)
o Qualification protocols
o Qualification reports
• Approve the required qualification documentation
• Active participation in the qualification meetings: challenging proposals, looking for solutions, ...
• Approve specific test documentation, created by specialised contractors
• Performing quality witnessing and approval of critical testings (ex. temperature mapping)
• Performing quality related user acceptance tests of IT systems
• Report the qualification status from a quality point of view to the QA project manager
• Strategic driven activities (PQP, URS, IA,..) will be executed at the site in Antwerp.
• All testing related activities will be based on the project location in Hainaut
Profil
• Good knowledge of Pharma regulations regarding qualification and validation
• Knowledge of Pharma regulations regarding distribution and warehousing is an advantage
• Experience with qualification of IT systems or equipment
• Experience with warehouse management systems/warehouse control systems
• Able to challenge proposals and deliverables of the qualification team
• Able to work in an independent way
• Strong Communication skills
• Languages: Dutch – English
Offre
- A position with responsability within a leading international company.
- Personal development through learning on the job and additional external trainings.
- A market oriented compensation, including a range of fringe benefits.