Senior CSV Officer (GCP)

☞ Proclinical Staffing

View: 153

Update day: 25-04-2024

Location: Lausanne Vaud VD

Category: Other IT - Software Executive management

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Contract

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Job content

Proclinical are partnering with a pharmaceutical organisation who are currently recruiting for an individual to join their team. This role is on a contract basis. The position that is available is for a Senior CSV Officer (GCP).

Responsibilities
  • Work alongside the CSV lead, business process owner and system owner.
  • Offer CSV training when suitable for users of specific systems.
  • Evaluate vendor validation Review vendor validation documentation and provide documented feedback and guidance.
  • Implement impact/risk analysis as well as document respective results.
  • Assist with the analysis and supervision of security procedures and incidents.
  • Contribute as a tester if deemed suitable and investigate test defects, resolution and reporting.
  • You will implement and respect internal processes and templates as well as assure compliance in organisation working procedures with GxP and linked validation compliance.
  • Other duties may be assigned to this role.
Key Skills And Requirements
  • Educated to a degree level in a scientific or IT field with at least 5 - 6 years of experience working in a CSV role within a pharmaceutical organisation.
  • Familiarity with CSV within a GCP setting.
  • Acquaintance with auditing in a pharmaceutical organisation would be advantageous.
  • Prior involvement working in data integrity projects would be beneficial.
  • Communication skills both verbally and in writing.
  • Fluency in the English language with knowledge in French would be advantageous.
  • Know-how of linked regulatory needs within the life sciences organisation such as GAMP 5, 21 CFR part 11, etc.
  • Able to think analytically with the ability to resolve issues.
  • Works well in a team as well as independently with the ability to work on various projects and tasks simultaneously.
  • Capable of prioritising workload.
If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at +41 61 508 73 40.

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.

#Engineering

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Deadline: 09-06-2024

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