Computerized System Validation (CSV) Consultant

The Operations Department manages DNDi’s corporate infrastructure globally across eight locations through its Business Development, Finance, Human Resources, Information Systems and Technology, Legal Affairs, and Project Management Office teams. The Department plays a central role in DNDi’s compliance and performance.

DNDi established its South-East Asia office in Kuala Lumpur in 2004. DNDi South-East Asia develops and supports R&D and access partnerships in Malaysia and the neighbouring region that are central to delivering DNDi’s global strategy, particularly in the areas of hepatitis C and dengue.

DNDi and the (GARDP) are seeking a Computerized System Validation (CSV) Consultant to lead
and oversee the validation of computerized systems used to support GxP (Good Clinical,
Laboratory, and Manufacturing Practices) activities. This role is critical to ensure that all
regulated computerized systems are validated and maintained in compliance with international
standards, applicable regulations, and industry best practices such as ICH E6 (R3), GAMP 5,FDA 21 CFR Part 11, EU Annex 11, and EMA guidelines on computerized systems and electronic
data in clinical trial.

TASKS AND RESPONSIBILITIES:

• Develop and support the implementation of CSV strategies and Validation Master Plans for
GxP-regulated systems
• Author, review, and/or advise on CSV documentation including:
• Risk assessments
• User Requirement Specifications (URS)
• Functional specifications
• Validation plans
• Test scripts (IQ/OQ/PQ)
• Final validation reports
• Ensure systems meet compliance requirements including 21 CFR Part 11, EU Annex 11, and
applicable ICH/GxP guidance
• Collaborate within the IST team and with QA, Clinical Teams, Regulatory, Pharmacovigilance
(PV), Data Management/Statistical teams, and system vendors to support proper planning
and execution of validation activities
• Conduct or support audits/assessments of DNDi and GARDP partners’ and providers’
system validation, and provide recommendations
• Support and advise on change control, deviation management, and periodic review
processes for validated systems
• Provide training, guidance, and knowledge sharing on CSV best practices to stakeholders
across the organization
• Maintain up-to-date knowledge of regulatory requirements and industry trends related to
computer system validation and data integrity

Additional Requirements
• Experience working in or with non-profit or global health organizations
• Familiarity with clinical trial systems (e.g., EDC, eTMF, CTMS)
• Knowledge of data privacy laws (e.g., GDPR) in relation to GxP systems

•  The CSV Consultant reports to DNDi SEA Director and assigned, or to other designated
  DNDi representatives as agreed.
• The CSV Consultant has a dotted line reporting to IST Director.

• Minimum 8 years of relevant professional experience, including experience in Computer
  System Validation (CSV) within a GxP-regulated environment (pharma, biotech, CRO or
  similar).
• In-depth knowledge of applicable regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP
  5, ICH Q-series).
• Experience with validation of SaaS/cloud-based solutions.
• Excellent project management and cross-functional communication skills.
• At least a bachelor’s degree in a relevant field (e.g., Life Sciences, Computer Science,
  Information Systems, or related discipline); specialist certifications or postgraduate
  qualifications are an advantage.

• Deliverables
  • CSV strategy inputs and/or Validation Master Plan (as applicable)
  • Reviewed or developed validation documentation (URS, protocols, reports, etc.)
  • Assessment reports and recommendations following audits or reviews
  • Support for compliance readiness and validation lifecycle activities
  • Knowledge sharing sessions or guidance materials (as required)

• Fluency in English
• Proficiency in local languages desirable
• Good knowledge of Microsoft Suite

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.