Analytical Quality & Compliance Specialist - long mission - Neuchâtel

☞ Kelly

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Update day: 26-03-2024

Location: Neuchâtel Neuchâtel NE

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job content

For our pharmaceutical client, localized in the French part of Switzerland, we are looking for a :

Analytical Quality and Compliance Specialist
  • Temporary mission till end of 2022
Your mission

The Analytical Quality & Compliance (AQ&C) Specialist will focus on Quality Assurance review and approval of technical documents pertaining the GMP analytical methods.

Your Responsibilities
  • Perform theQA review/approval of technical documentation, including but not limited to: Analytical method validation protocols and reports for in process, release, and stability testingAnalytical method procedures and associated change controlsMethod technical transfer protocols and reportsReference material and critical reagents qualification protocols and reportsStandard Operation Procedures and other controlled documents
  • Collaborate with clinical or commerical analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical transfer of analytical methods or qualification of reference material and critical reagents
  • Communicate, share and escalate issues within team for consensus resolution
  • Assist in the development of procedural and other guidance documents for Quality and QC functions
Your profile
  • Master’s degree or equivalent in chemistry or life sciences
  • Experience in QC, QA, analytical method development or method validation functions
  • Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable.
  • Experience and/or knowledge of QC biologics testing
  • Fluent in English
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Deadline: 10-05-2024

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