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Analytical compliance record specialist (m/f/d) - 873690/1

Basel
Hays
Inserat online seit: 9 Mai
Beschreibung

The ideal candidate holds a
Master’s degree (or higher) in Organic Chemistry, Analytical Chemistry, or Pharmacy, possesses at least 3 years of professional experience in Quality Control, and has excellent GMP knowledge.
General Information:
Start Date: asap Latest Possible Start Date: 01.08.2026 Workload: 100% Home Office: 40%
Tasks & Responsibilities:

Work in a modern quality control organization in compliance with cGMP regulations.
Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
Facilitation and Documentation of Root Cause Analyses
Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
Critical evaluation of own work results
Key role in ensuring an appropriate GMP standard in the department
Scientific and regulatory documentation of the work done

Must Haves:

A university degree (Bachelor’s, Master’s, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology)
OR a Laboratory Technician background will be considered if they possess over 10 years of high-level GMP experience
Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise)
Demonstrated ability in managing compliance records, specifically Deviations, Change Control, a

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