Description
We are looking for a
QA Compliance Officer (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Neuchatel
Branch: Tabakverarbeitung
Your tasks:
- Review activity records for compliance with the quality management system
- Validation of laboratory equipment and QA processes
- Collaborate with other QA Officers to provide support, training, validation, advice, audits, inspection where required for the biomedical research organization, in order to support the compliant execution of the QMS
- Create and advise on and support the continual improvement of Standard Operating Procedures and Work Instructions
Your qualifications
- Master’s degree in Engineering or Life Sciences
- Excellent working knowledge/understanding of Quality Assurance and Standards (ISO 9001, ISO 17025, FDA and EU GxP, ICH Q).
- Excellent working knowledge and practical application of Quality Risk Management Tools (ISO14971)
- Fluent in both written / spoken English (proficiency in French would be an asset)
- Working knowledge/understanding of FDA regulatory requirements applicable to computerized systems (21CFR§11) preferred
- Working knowledge/understanding of regulatory expectations regarding data integrity preferred
Skills:
- Quality manager