Senior CSV QA Manager - SCSV-QAM-IDO-3786

☞ Xplore Life Science

View: 152

Update day: 25-04-2024

Location: Allschwil Basel-Landschaft BL

Category: Quality Assurance / Quality Control

Industry: Pharmaceutical Manufacturing

Job type: Contract

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Xplore Life Science is hiring an experiencedCSV QA Manager.
The role is for a global leading biopharmaceutical company headquartered in Allschwill, Switzerland.

**You must have valid right to work in Switzerland

This is a freelance contract role with a minimum 12-month duration and immediate start.
Key Responsibilities:
  • Ensure the compliance of the computerized system.
  • Ensure that GxP regulated systems are managed in accordance with regulatory requirements.
  • Perform CSV activities and support efficient integration of Data Integrity.
  • Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11.
  • Ensure compliance of the computerized system lifecycle.
  • Perform and coordinate internal and external audits.
Requirements:
  • Master’s degree within the pharmaceutical industry.
  • At least 7 years’ experience in Computerized Systems Validation (CSV).
  • Understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11.
  • Fluent in English. German and/or French are an advantage.

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Deadline: 09-06-2024

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