Computer System Validation (CSV) Manager (FDA, part 11) - Deloitte

Zaventem
2018-09-14
2018-09-21

Deloitte is a world leading professional services firm, providing accounting and auditing services, management consulting and legal and tax advice. In Belgium we are the largest professional service provider. Our offices offer services to multi-national and large organisations, public institutions and innumerable small, fast-growing companies. Thanks to a strong regional presence and our multi-disciplinary approach, we are ideally placed to meet the requirements of a wide range of public institutions and small and large companies.

 

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.

 

Your Responsibilities:

 

As a Computer System Validation (CSV) Manager you will:

 

  • 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 requirements;
  • Assist in setting up a quality management system.

 

Desirable Skills  

  • You obtained 5 to 8 years of experience in computer system validation (CSV);
  • You have experience with validation of ERP systems;
  • Good understanding of quality management systems;
  • You have 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;
  • You have fluent language skills in English, Dutch and French;
  • You are a good organizer and can show diplomacy and creativity. Your approach is client and result oriented and you have excellent social and communication skills.

 

Our Offer

 

  • A challenging, innovating environment with a good team spirit where personal development and growth are encouraged;
  • A people focused culture of continuous learning and coaching;
  • An attractive and competitive salary package with fringe benefits;
  • Real career opportunities.