About this role
About the role: The Validation Specialist is responsible for maintaining the Computer System Validation (CSV) framework, policies and all associated template documents. The CSV will plan, execute, document, and maintain CSV activities to ensure all digital systems comply with regulatory requirements and NZCR SOPs and policies.
The key responsibilities of the Validation Specialist include leading validation efforts across all digital platforms, identifying gaps or process improvements in validation procedures, and producing documentation to support validation efforts. The role also requires an extremely high-level attention to detail, in conjunction with a sound understanding of validation models and how to apply them to various digital systems.
The Validation Specialist will achieve effective outcomes as follows:
• Lead validation activities (IQ/OQ/PQ) across digital systems;
• Ensure compliance with ICH GCP, FDA 21 CFR Part 11, EMA, GAMP 5;
• Work closely with IT, QA, and business teams to meet user and regulatory needs;
• Outline validation approaches and explain associated documentation in audits by external parties;
• Author and review validation plans, risk assessments, and traceability matrices;
• Participate in vendor qualifications, both in-person and virtual;
• Contribute to data integrity programs;
• Train staff and promote a quality focused culture.
About you:
• Formal qualifications in CSV (Required);
• 5+ years’ experience in CSV in pharma, biotech, medical devices or other highly regulated industry;
• Certification in ICH GCP (Desirable);
• Qualifications in GAMP 5 (Desirable);
• Qualifications in data integrity principles (Desirable);
• Strong knowledge of ICH GCP, and FDA regulations;
• Experience validating cloud-based solutions;
• Detail oriented, analytical, and proactive team player;
• A clear communicator, with the ability to explain complex concepts to a wide variety of audiences
About NZCR
Established in 2020 through the merger of Auckland Clinical Studies (ACS) and Christchurch Clinical Studies Trust (CCST), NZCR is at the forefront of early-phase clinical research in New Zealand. With over 35 years of combined research excellence, we have successfully completed more than 750 trials involving over 15,000 participants.
Our physician-led, world-class research units in Auckland, Christchurch, Wellington and Hamilton conduct complex studies in both healthy participants and patient populations. Partnering with global pharmaceutical and biotech companies, we deliver excellence in clinical research while exploring potential new medicines that improve health outcomes. We place our participants at the centre of everything we do, ensuring their safety, comfort and wellbeing throughout their research journey.