Do you have a keen eye for detail and a passion for compliance, we want to hear from you, this Senior QA Associate for Quality Systems/CSV is the perfect opportunity for you!
This role will ensure compliance with regulatory standards and maintain data integrity across GxP systems. Your contributions will be vital in upholding and enhancing the Quality Management System, supporting process improvements, and collaborating with various departments to drive regulatory compliance.
Responsibilities:
- Oversee quality assurance for CSV activities, ensuring GxP systems are validated and compliant.
- Assess and approve deviations, change controls, and CAPA.
- Contribute to continuous improvement initiatives and the Regulatory Intelligence program.
- Identify and mitigate risks related to data integrity in projects and data handling.
- Develop and deliver training on QMS processes, CSV, and Data Integrity.
- Collaborate cross-functionally to ensure compliance and initiate process improvements.
- Support functional areas by developing procedures and validation documents.
- Participate in audits and inspections as a CSV/DI expert and Quality Systems SME.
- Manage supplier qualifications and review Quality Agreements.
Key Skills and Requirements:
- Ability to manage multiple projects independently.
- Excellent communication and collaboration skills.
- Proactive approach to continuous improvement.
- Knowledge of GMP and/or GCP.
- Experience in Computerized System Validation and Data Integrity principles.
- Project management experience.
- Familiarity with Lean Six Sigma methodology.
- Proficiency in English.
If you are having difficulty in applying or if you have any questions, please contact George Kyriacou at g.kyriacou@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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