Beschreibung
Acceptance Activities Consultant - German & English
Edelway is a Swiss Professional Services Consultancy. One of our best clients, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Senior Acceptance Activities Consultant with ideally experience in Statistic to join them on a long term basis.
Required languages: Fluent English; Conversational German
THE ROLE
*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)
*Make recommendations to achieve compliance where shortfalls are found
*Provide Audit reports as directed
*Develop the new Standard for Inspection Planning on statistic on the EU
*Well know statistics
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
YOUR PROFILE
*Minimum of 4 years quality planning
*Experience in Statistic is a plus
*Prior experience in medical device/pharmaceutical remediation is a plus
*Familiarity and interaction experience with regulatory auditing bodies preferred
*Documented training in FDA QSR, ISO required
*Proficient in the use of spreadsheet software (Access/Excel etc.)
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.