Description
QA Expert - Device DevelopmentOur Global Medical Device and Pharmaceutical client is looking for an experienced QA Expert to support them in reviewing key areas of their QA processes including SOPs, historical submission documents, deviations and CAPAs.
This role will be part of a wider quality improvement project being carried out across all QA work streams to drive regulatory compliance to an outstanding level.
Key Responsibilities:
• Provide expertise to the team in relation to FDA/GMP compliance in the area of medical device development (for drug delivery).
• Review of SOP with regards to CFR 820, HQ directives and local regulatory authority requirements.
• Review current deviation and CAPA strategy - suggest improvements to process and productivity.
• Help close off any challenging CAPAs/Deviations.
• Review historical submission documents for medical devices for compliance to current GMP/FDA standards - carry out gap analysis and advise on requirements to close these.
Requirements
• Extensive experience in QA regulations and requirements for device development, specifically 21 CFR 820.
• Knowledge and experience of the medical device industry.
• Sound QA background and proven experience of supporting Quality Improvement initiatives.
• Experience of managing and closing CAPAs and Deviations - previous experience of review of strategy very beneficial.
• Experience working both independently and in a team-oriented, collaborative environment.
• Creative and solution-orientated thinking, ability to advise and support creation of new solutions.
• Strong oral and written communications skills in both German and English