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- Plan and coordinate computer system validation (CSV) projects (FDA, Part 11)
- Provide regulatory compliance and computer validation guidance and support
- Create system validation deliverables (validation plan, user requirements, risk analysis, test protocols, validation reports)
- Perform a risk analysis
- Plan and coordinate the validation testing
- Perform system audits for compliance with good practices and regulatory requirement
- Assist in setting up a quality management system.
- 5 to 8 years of experience in computer system validation (CSV);
- Experience with validation of ERP systems;
- Good understanding of quality management systems;
- Experience and good understanding of the regulations and industry standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK;
- Experience in working in regulated industries;
- Fluent language skills in English, Dutch and French;
- Good organizer and can show diplomacy and creativity. Your approach is client and result oriented and you have excellent social and communication skills.
Our Risk Advisory practice
is a global leader in helping clients manage risk and uncertainty from the boardroom to the network. We provide a broad array of services that allow our clients around the world to better measure, manage and control risk to enhance the reliability of systems and processes throughout their organization.
The commercial world is constantly changing. Our clients face new regulations, shifting legislation and fluctuating economic and financial risk. Our life sciences regulatory compliance team
knows that risks are just opportunities in reverse. We’re passionate about what we do because we know our role is to give our clients more control of their operational and technology processes. By identifying risks, we help our clients spot pitfalls before they become problems, weigh the pros and cons, and connect the dots to make informed, intelligent, and insightful decisions that help them mitigate risks and maximise opportunities.
Who is Deloitte?
World-leading professional services firm, we offer value added services in audit & assurance, risk advisory, accounting, tax & legal, consulting and financial advisory.
+6.000 dedicated professionals, active in +10 offices throughout the country, take great pride in supporting our clients with multidisciplinary expertise, industry knowledge, and innovative solutions. We offer services to a wide variety of clients, from national and international companies, small, fast-growing and large organizations to public institutions and governmental authorities.
Be the true you!
We foster diversity and inclusion and encourage you to bring your authentic self to work. Explore, question and collaborate while building a career that inspires and energies you.
Never stop growing!
Diversity of thought makes us stronger. At Deloitte, we tailor a personalized learning experience, offering you the opportunity to grow at your own pace and achieve maximum impact.
We practice what we preach!
As a Purpose-led organisation, at the heart of everything we do is a set of timeless principles and unifying values
Life looks different for each of us, so we created a varied benefits package that you can tap into:
- My Benefits My Choice, a flexible rewards plan tailored to your lifestyle and priorities
- Sustainable transport options offered by Mobility@Deloitte
- Flexible work arrangements for all and initiatives supported by Parents@Deloitte
- Wellbeing tips and activities powered by Energise@Deloitte
- Topped off with other health benefits and insurance opportunities
Empowering our employees with flexible work arrangements
remains essential in today's reality:
Join us to make an impact together! Apply now!
- Hybrid workplace: combination of home office and on-site (+10 offices in Belgium or client's premises).
- Part-time employment: all our jobs are open to part-time work under a 90% or 80% regime