Beschreibung
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Subject Matter Expert: Materials Control to join them on a long term basis (contract or permanent).
Language: English & German, other languages are a plus
Start Date: ASAP
Rate: Excellent
THE ROLE:
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 for the Medical Device Industry (ISO, FDA, etc.).
*Audit site procedures to the above mentioned standards and report on findings (both current state and retrospectively).
*Make recommendations to achieve compliance where shortfalls are found.
*Provide Audit reports as directed.
* Perform CAPA verification of effectiveness as necessary.
*Be willing and able to travel to other sites in Europe (Switzerland, Germany, Austria) as required.
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
YOUR PROFILE:
*Minimum of 4 years quality/compliance experience in the medical device or pharmaceutical industries.
*Prior experience in medical device/pharmaceutical remediation preferred.
*Familiarity and interaction experience with regulatory auditing bodies preferred.
*Documented training in FDA QSR, ISO required.
* Proficient in the use of Microsoft Office, MS Visio and/or MS Project are a plus
*Some ERP Knowledge (preferably Agile, JD Edwards and SAP)
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.