COMPUTER SYSTEM VALIDATION OFFICER (H/F)

Job description

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus France Office:
- 18/20 rue Clément Bayard
- 92300 Levallois-Perret
Keyrus Belgium Offices:
- Chée de Louvain 88
- Waterloo-Lasne
- Rue Emile Francqui, 1
- Mont-Saint-Guibert
- Nijverheidslaan 3,
- Strombeeck Bever
Poste et missions:
We are looking for a Computer System Validation Officer.
You will support the development and validation of new and existing computer systems used in clinical research, acting as the Quality Assurance (QA) representative of Good Clinical Practices (GCP) and Data Privacy requirements. This will require close working relationships with clinical business stakeholders and the IT Risk & Compliance team, to ensure delivery of high quality IT systems which are fit for purpose. An understanding of clinical business processes and regulatory requirements is critical.
Your tasks and responsibilities will be to :
- Support computer system development projects as the QA representative of GCP requirements for clinical business processes
- Ensure new clinical computer systems have been assessed for GCP risks prior to implementation and that they will address all applicable regulations and Data Privacy requirements
- Review and approve agreed deliverables from computer system validation projects in accordance with Standard Operating Procedures (SOPs)
- Work closely with IT Risk & Compliance team to ensure IT and GCP quality issues and requirements are managed effectively on new and existing clinical computer systems
- Provide regulatory interpretation and advice to business areas and staff supporting clinical regulated computer systems
- Participate in preparation and support activities for GCP-regulated computer systems during regulatory inspections
- Facilitate Level 2 assessments of the validation status of GCP-regulated computer systems
- Be ready to answer questions coming from auditors or inspectors in the CSV remit.
- Assess regulatory risk associated with computer systems and provide guidance on the management and mitigation of risk
You will work closely with the Computer Systems QA team to ensure consistent regulatory interpretation. Your role requires awareness of appropriate national and international legislation and guidelines that affect the GCP-regulated computer systems in R&D areas.
Profil:
Required Experience & Knowledge :
- First experience in development or validation of computer systems
- Demonstrable knowledge of the regulated pharmaceutical industry and the computer compliance regulations and expectations that apply to clinical research processes
- Possess excellent planning and organizational skills
- Demonstrate effective problem solving and decision making
- Able to build and maintain effective internal business relationships with IT, Quality and clinical business areas
- Able to work in a matrix organization
Soft skills :
- Team player and autonomous
- Effective and influential communicator (listening and dialog), both in writing and verbally
- Able to identify and express compliance risks in the context of a business process
- Proactive and Positive attitude
- Committed to his/her projects with the sense of excellence.
Education, Methodology & Certification Requirements:
- Master degree in Sciences or Engineering.
- Have a working knowledge of one or more of GLP/GCP/GMP/PV regulations
- Certification in Computer System Validation is a Plus
ICT Skills (software, operating systems, hardware, etc.):
- SAP
- Office Tools
- Any Clinical Tools (eCRF, CTMS, ePRO, LIMS, ….)
Language Proficiency Requirements:
- French & English: Fluent
Come and join us in Belgium !
What are the advantages to work at Keyrus Biopharma Belgium?
- You will boost your career at the international level. You will work with colleagues from all over the world on global projects. You will work with international teams, projects and clients!
- You will enjoy the famous Belgian culture focused on open, simplicity and work-life balance!
- You will have a high quality of life in Belgium (Cost of life lower than other EU big capital cities), famous Belgian gastronomy, lots of green areas…).
- You will work in our offices located in the middle of countryside. You will have the opportunity to attend some internal events, to do sport with colleagues, to possibly work from home if needed and to have flexibility in your working hours.
- Brussels is also a crossroads in Europe. If you like travelling, don’t miss the closest cities like Paris, London