QA/CSV Engineer

Are you a CSV Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: CSV Engineer

Location: Turnhoutseweg, Belgium

Rate: Open

Openings: 1 Engineer

Contract/Perm: Contract (12-Months)

A Fantastic new role has just opened up at one of our leading Belgian based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities:

• To assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Beerse/Geel computerized systems.
• Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis's, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines, J&J and Janssen policies and standards. ·
• Be part of engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
• Be a member of cross-functional teams to realize cross-departmental objectives · Address and follow-up of deviations occurred during execution of qualification/validation activities. Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case. Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,…), MAP, etc.

Requirements:

• Knowledge of Quality auditing
• Knowledge of Software quality metrics
• Capacity to 'translate' technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Good project management skills.
• Good problem solving skills.
• University degree or similar
• Fluent in English (written and spoken)
• Fluent in Dutch
• Quality Management System
• Process control and IT systems used within pharmaceutical or chemical manufacturing environment: MES, ERP, PLCs, warehouse management systems, laboratory control systems, environmental monitoring systems, historian…
• Problem report, change request systems. (f.e. Trackwise)
• Document Management systems (f.e. Docspace/TruVault)
• Training Systems (f.e. ComplianceWire)
• Microsoft OS, networks, virus protection
• SAP systems
• Test tools (f.e. HP ALM)

If you are interested, please do not hesitate to email or call me!

S.Hubert@Proclinical.com

DL: +44 203 949 8594

CH: +41 61 508 7073

Mob: +44 7592 053 700