KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Senior Auditor - Technology & CSV
December 11
KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Description
• Responsible for maintaining the quality and compliance of clinical trials • Provide expert consultancy and compliance advice within the company for current and emerging technology related topics • Perform a variety of audit activities including internal process audits • Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems • Participate as a Technology related Subject Matter Expert during inspections, sponsor audits and in support of Quality Issues • Mentor and train junior staff.
Requirements
• Bachelor's degree in Life Sciences, Pharmacy, IT or related field; advanced degree preferred • Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare or CRO industry • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas • Proven auditing experience of computerized systems, processes and vendors used in a clinical development and manufacturing setting • In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks and emerging trends (e.g. 21 CFR Part 11, Annex 11 & EMA Guidance, Computer Software Assurance, Agile, ITIL, GDPR, Information Security, AI) • Familiar with regulations and guidance governing clinical trials and drug development (e.g. ICH, FDA, EMA covering GLP, GCP, GVP, GMP, GDP and Medical Devices) • Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels • Ability to travel more than 20%.
Benefits
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead • Global Employee Assistance Program • Life assurance • Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.
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