IT Validation Professional - Cape Town at Roche

Key Challenges

• This role will be situated within the Security, Quality and Compliance Chapter in Global Informatics and you will be also part of the Cape Town Informatics Team. The IT Validation Professional ensures compliance and integrity of validated computer systems, oversees protocol design, testing, change management, and provides end-user training. They safeguard system reliability and regulatory compliance, supporting essential organizational operations. Reporting to the Lead of the Computer Software Assurance (EMEA/Canada) Section, the successful candidate will be responsible for the following:
• Leading IT validation and qualification for projects and systems maintenance, mainly for lab systems and software
• Authoring and reviewing validation plans, reports and deliverable registries, and other related deliverables, records, and evidence
• Review system documentation according to CSV corporate SOPs, and regulatory guidance
• Consulting and supporting systems in scope regulators (e.g. EMA or FDA, applying CFR 21 FDA Part 11, Annex 11, ISO 13485:2016) for inspection and audit
• Troubleshooting activities related to computer systems validation, such as root cause analysis, deviations, and system risk assessments
• Support internal and external audit activities related to CSV
• Collaborate with cross-functional teams to ensure compliance with corporate policies and procedures regarding computer software validation

Who You Are

Qualifications and Educational Requirements

• Technical degree/certification in Computer Science or related field of study and/or 
• 1-2 years experience in IT & Software Validation (CSV, GAMP 5, ISO 13485:2016), preferably in the healthcare environment.
• Professional experience with validation in a laboratory environment (preferred)

Knowledge, Skills or Abilities

• Strong communication skills (oral and written) with the ability to present at all functional levels.
• Experience in Agile methodologies (Scrum/SAFe) preferred, certification a plus.
• Collaborate with cross-functional, global teams to develop efficient validation processes for frequent releases.
• Assertiveness, good stakeholder management skills and willingness to lead
• Demonstrate analytical problem-solving skills, teamwork, and time management.