QA CSV Specialist

☞ Proclinical Staffing

Visualizza: 158

Giorno di aggiornamento: 17-04-2024

Località: Visp Valais VS

Categoria: Garanzia di qualità / Controllo di qualità

Industria: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Posizione: Entry level

Tipo di lavoro: Contract

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Contenuto del lavoro

Proclinical are recruiting a QA CSV Specialist for a pharmaceutical establishment. This role is on a contract basis. The client is focused on facilitating a healthier society.

Responsibilities
  • You will serve as an SME and offer leadership and suggestions to both internal and/or external project shareholders.
  • The ideal candidate will serve as a representative of quality in the CAPEX project corporation concerning CSV.
  • Guarantee CSV deliverables meet international processes, regulatory needs and policies.
  • Accountable for computerised system validation deliverables for new large scale mammalian establishments, equipment and utilities linked to the GMP manufacturing of biologics.
  • Evaluate and release quality connected CSV project deliverables.
  • Other duties may be assigned to this role.
Key Skills And Requirements
  • Educated to a degree level in a computer science, engineering, life science or similar discipline.
  • Acquaintance with GMP regulated pharmaceutical organisation projects, ideally within a Quality Unit role.
  • Expertise on CSV, data integrity and linked regulations such as CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each.
  • Familiarity with engaging with all kinds of interfaces within the establishment and with regulatory agencies such as Swissmedic, FDA, etc.
  • Know-how of MES (Syncade), and DCS (DeltaV).
  • Fluency in the English language with knowledge in German would be beneficial for the role.
If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert at +41 61 508 70 73.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#QACompliance

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Scadenza: 01-06-2024

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