QA Computer System Validation Consultant
WHAT ARE YOUR RESPONSIBILITIES?
- Assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for 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, 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.
WHO ARE WE LOOKING FOR?
- Knowledge of:
- cGMP’s: 21CFR11, 21CFR210, 21CFR211, Eudralex Volume 4 and annex 11, MHRA GFI on Data Integrity and related GMP Guidelines and Preambles.
- GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System,…).
- SW development and testing processes.
- Quality auditing
- 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 in Dutch and English
- Good project management skills.
- Good problem solving skills.
WHAT DOES QBD OFFER YOU?
- A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- Personal and professional development through guidance, education and knowledge sharing
- A competence development model focused on your personal ambitions
- An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.
Interested? Apply now by sending us your CV and motivation.