ProClinical is hiring a QA Auditor / Manager for a global Clinical Research Organisation (CRO) who is leader in research-based drug development. This is an exciting opportunity for a QA Auditor, based in Singapore.
- Coordinating and conducting internal project-level, process and system audits
- Hosting audits by Sponsors and Regulatory Inspectors; providing internal support and guidance on outcomes
- Coordinating, conducting, and tracking Regulatory Training (ICH/GCP, ISO);
- Involvement QA Management in development and execution of strategic and tactical objectives
Skills and Requirements:
- Candidate must have a BA/BS (or a BSN) in Life Sciences
- 3 - 5 years of experience in a QA department in a related industry required
- Knowledge and application of GLP is required. GCP is a plus
- Experience in conducting audits of device clinical trials, critical vendor assessments (e.g., IRB, Archiving, Clinical Labs); and thorough knowledge of Medical Device QMS requirements and QSIT
- Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives
- Independent thinking and planning ability
- Excellent written and verbal communication skills
- Good teamwork skills, as well as the ability to work independently.
- Travel Up to 30%
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 6499 7144 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.