Quality & Compliance Consultant

Bern  ‐ Vor Ort
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Schlagworte

Beschreibung

Quality & Compliance Consultant

One of our best clients in Switzerland, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Senior Quality & Compliance Consultant to join them at the early stage of a global remediation program.

Start date: ASAP
Languages: English. German is a plus.

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' procedures 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
*Perform CAPA root cause and corrective/preventive action as necessary
*Perform CAPA verification of effectiveness as necessary
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
*Analyzing reports NCR (Nomenclature Change Request), CAPA files
*Analyzing inspection activities
*Analyzing maintenance reports and monitoring data
*Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices
*Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc

YOUR PROFILE

*Minimum of 5 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 spreadsheet software (Access/Excel etc.
*Be versed in the process validation methodology, NCR, CAPA, inspection and calibration, as defined by GAMP.
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines

If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.

Start
keine Angabe
Dauer
Long term
Von
Edelway
Eingestellt
07.06.2013
Projekt-ID:
548311
Vertragsart
Freiberuflich
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