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FIFisher Clinical Services GmbH

QA Deviation Management Specialist(m/w/x)

Allschwil
Full-timeOn-siteExperienced

Reviewing and approving deviations, complaint investigations, and CAPAs for clinical trial supply solutions. Minimum 2 years of deviation investigation and QMS experience required. Mentoring investigators and ensuring cGMP compliance.

Requirements

  • Degree or relevant experience in pharmaceutical industry, QC/QA, medication handling, life sciences, or related scientific field
  • Preferred study fields: Biology, Chemistry, Engineering, Life Sciences, or equivalent
  • Knowledge of cGMP regulations and/or international regulatory requirements
  • Minimum 2 years experience in deviation investigations, CAPA, change control, root cause analysis
  • Minimum 2 years experience with quality management systems and documentation (e.g., TrackWise or equivalent)
  • German B2 or higher, English B2 or higher
  • Experience delivering training sessions
  • Excellent communication and organizational skills
  • High accuracy, accountability, and efficiency
  • Ability to work independently and collaboratively in cross-functional teams
  • Ability to manage priorities and meet timelines

Tasks

  • Review and approve deviations
  • Review and approve complaint investigations
  • Review and approve CAPAs
  • Review and approve effectiveness checks
  • Mentor investigators to improve investigation quality
  • Mentor investigators to improve CAPA quality
  • Coordinate investigation approvals within timelines
  • Support batch release activities
  • Analyze data to improve Quality KPIs
  • Participate in Practical Process Improvement initiatives
  • Support quality and efficiency projects
  • Provide support to the broader Quality organization
  • Support internal audits
  • Support client audits
  • Support regulatory inspections

Work Experience

  • 2 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • TrackWise
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fisher Clinical Services GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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