IT Validation Professional

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Opportunity
Roche Diagnostics Cape Town invites applications for an exciting opportunity to join their Informatics team as a permanent IT Validation Professional. 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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.