Senior Quality Assurance Specialist
1 month ago
Job Summary:
We are seeking a highly skilled Senior Auditor, Quality Assurance to join our team at Pharmiweb. As a Senior Auditor, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
About the Role:
The Senior Auditor, Quality Assurance will be responsible for providing expert consultancy and compliance advice on technology-related topics, such as eClinical Systems and AI. You will perform internal process audits, technology vendor audits, computerized system and equipment audits. Additionally, you will perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems. The ideal candidate will participate as a Technology-related Subject Matter Expert during inspections and sponsor audits and mentor and train junior staff.
Key Responsibilities:
- Provide expert consultancy and compliance advice on technology-related topics, such as eClinical Systems and AI
- Perform internal process audits, technology vendor audits, computerized system and equipment audits
- Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems
- Participate as a Technology-related Subject Matter Expert during inspections and sponsor audits
- 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
- 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
- Familiar with regulations governing clinical trials and drug development
- Excellent communication and interpersonal skills
What ICON Offers:
- Competitive salary
- Annual leave entitlements
- Health insurance offerings
- Retail savings plan
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
About ICON:
At Pharmiweb, diversity, inclusion, and belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. We're committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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