QA Compliance Officer (m/f)

REFERENZNUMMER:

307017/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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 Q9-10-11).
-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

WEITERE QUALIFIKATIONEN:

Quality manager