QA CSV Specialist

Location Basel
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Ivan De Marcos Ospino

Contact email: i.ospino@panda-int.com
Job ref: 19336
Published: 29 days ago

Currently working with a Biotech Client in Switzerland who are in need of support from a QA CSV Specialist for ongoing high-level projects. In this role you will manage the CSV projects from a QA perspective.

 

Responsibilities:

  • Managing the CSV projects independently.
  • Support in different projects in lab, manufacturing, distribution, and clinical departments.
  • Write risk assessments for the projects and support the validation.
  • You will be the QA contact point and representant for these project so will be the go-to person for any issues. Generally, you won’t write the documentation but will support and advise Validation teams.
  • Participate in internal, external and suppliers audits, working with the GxP systems and supporting the validation.

 

Requirements:

  • QA background in GMP Biopharma environment with extensive knowledge of CSV, data integrity and GxP.
  • Must be able to work independently with GAMP5, 21CFR Part 11, Annex11 and GxP
  • You are very motivated and can prove the knowledge you have in these fields.
  • Fluent in English is a must.

 

 

Location: Basel

 

Workload: Hybrid

 

Duration: Between 6 and 12 months (possibility to extend)

 

Interested?

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

 

For more information, please contact Ivan de Marcos Ospino on +31 (0)20 20 44 502 or i.ospino@panda-int.com