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GCP/PV/GLP Regulatory Affairs Specialist

vor 1 Woche

Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

Job Description

We are a leading pharmaceutical company seeking an experienced Quality Assurance Manager to join our team. As a key member of our global quality management function, you will play a critical role in ensuring the quality and integrity of our operations.

Main Responsibilities:

  • Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies / compounds
  • Support and coordinate vendor qualification activities, including audits
  • Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
  • Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
  • Ensure audit results are formally tracked, recorded and reported
  • Coordinate and lead internal or external training activities
  • Support departmental and cross-functional compliance initiatives as assigned
  • Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies

Requirements:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Minimum 5 years of experience in the pharmaceutical industry and a minimum of 3 years' experience in QA GCP/GVP
  • University or master's degree in pharmacy, chemistry, or equivalent
  • Working knowledge of GCP and PV legislation
  • Knowledge of product development processes and experience in cross-functional teamwork
  • Experience in auditing GCP, PV and GLP, an auditor qualification would be an asset
  • Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM, other HA)
  • Ability to work both independently and collaboratively, well-organized and structured
  • Excellent communication and presentation skills at different levels
  • Fluency in English written and spoken is essential, any other language would be beneficial