Senior Auditor for Quality Assurance - Perm - Durham, NC
Proclinical is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.
Primary Responsibilities:
The successful candidate will have a strong understanding of Good Clinical Practices (GCP), Good Documentation Practices (GDP), and other applicable regulatory and ethical requirements.
Skills & Requirements:
- Bachelor's degree or equivalent in a scientific, management, or related discipline.
- Experience in quality assurance, quality control, and/or validation.
- Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality.
- Excellent presentation skills.
- Proficiency in English.
The Senior Auditor for Quality Assurance's responsibilities will be:
- Maintain the Quality Management System (QMS) in line with current GCP, GDP, and other relevant regulations.
- Generate, review, and implement SOPs and associated training.
- Conduct vendor and internal audits, and essential document audits.
- Generate, approve, and implement external and internal audit plans and processes.
- Coordinate and host sponsor audits; respond to audit observations.
- Support company regulatory agency inspections.
- Track GCP quality system metrics such as quality events, CAPAs, and deviations.
- Support and adhere to all aspects of the company's Quality System.
- Comply with the company's data integrity and business ethics requirements.
- Lead Quality Assurance in support of computer system validation activities.
- Assist Department leadership with administrative and management functions as required.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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