Senior CSV Specialist

vor 4 Wochen


YverdonlesBains, Waadt, Schweiz gloor&lang AG Vollzeit
Contractor - 12 months

Our client, a leading international biopharmaceutical company, is seeking a highly skilled professional to join their team as a CSV Specialist. With globally established and recognized products in innovative therapeutic areas, this company is a pioneer in the industry.

The ideal candidate will have expertise in Computer System Validation (CSV) in the pharmaceutical environment and proficiency in French and English. The role involves the implementation and validation of off-the-shelf and configurable systems, regulated by GMP, as well as collaboration on GAMP 5 worldwide/interconnected systems.

Key Responsibilities:

  • Explain and obtain IT requirements and GMP regulations from vendors, and customize systems as needed to comply with GMP.
  • Guarantee data integrity of systems in their environment and process.
  • Design, elicit, analyze, document, and validate detailed user, functional, and non-functional requirements to ensure business needs are met.
  • Adjust deliverables, their quality, and complexity to meet timelines and fit validation approaches.
  • Assist in translating compliance requirements into test conditions and expected results for application functionality and acceptance testing.
  • Drive development and execution of change management and training throughout the organization during system implementation and ongoing use.

Requirements:

  • Pharmaceutical, biotechnology, or life science industry experience is mandatory.
  • App 5-10 years' experience as an IT Engineer, running projects from requirements to delivery of final products and documentation.
  • Familiarity with change management tools and regulated document authoring.
  • COTS and web-based requirements, architecture, Agile/SCRUM methodology.
  • Proven experience in the installation and qualification of Aveva-PI suites and Building Automation systems (Desigo, RMS Rotronic) is a strong plus.
  • Experience in Computer System Validation and awareness of 21-CFR Part 11, Eudralex, MHRA.
  • Fully operational in French and English.

We are looking for a highly skilled professional with strong analytical and problem-solving skills, who can work autonomously and influence colleagues to achieve positive outcomes.

About gloor&lang AG:

gloor&lang AG is a leading recruitment agency specializing in life science talents. We are committed to providing exceptional service and expertise to our clients and candidates.


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