Beschreibung
An international company situated in German part of Switzerland is looking for a Freelancer with experience with Medical Devices for a 6 Months Project.Duties and Responsibilities:
- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Provide Audit reports as directed.
- Perform analyze and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background on statistics.
- Background on validation.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Generate DCRs / DCOs that these achieve the regulatory and the business requests
- Fluent German spoken and written English is an advantage
- Team player.
- Be able to manage effectively multiple priorities and tasks.
Experience:
- Minimum of 4 years quality planning
- Compliance experience in the medical device.
- Prior experience in medical device / pharmaceutical remediation preferred.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO required.
My name is Robert Galansky, I am responsible for Medical Devices - QA/QC Freelance role in Switzerland. If you feel you are suitable for this position I am looking for your online application.
To find out more about Real please visit www.realstaffing.com