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CSV Senior Officer

Ref: JN-082022-338720

Posted on 11 August 2022
Job Location
Vaud
Category
Life Sciences

Modis Life Sciences is looking for one of it's clients a:

Responsibilities:

  • Create key CSV deliverables and assist business units in writing CSV documentation (e.g.,
  • Validation Plan, Functional Requirements Specification, Test Scripts, Validation Report),
  • based upon approved templates, processes and ensures proper filing in respective document
  • management system.
  • Review vendor validation documentation and provide documented feedback and guidance.
  • Execute Impact and Risk Analysis and document respective outcome.
  • Support the analysis and monitoring of security processes and incidents.
  • Support maintenance of system inventories, changes, incidents, ensuring accuracy
  • and completeness at all times.
  • Participate as a “Tester” if appropriate and investigate Test Defects, resolution and
  • reporting.
  • Provide CSV training as appropriate for users of specific systems.
  • Apply and respect internal procedures and templates and ensure compliance in company
  • working processes with GxP and related validation compliance.
  • Closely collaborate with the CSV Lead, Business Process Owner and System Owner and
  • understand the synergy between business, Quality and IT.

Profile:

  • At least a Bachelor in Sciences or in IT with 5-6 years working experience as CSV in the
  • pharmaceutical industry.
  • CSV Experience in a GCP environment.
  • Auditing experience in the pharmaceutical industry is a plus.
  • Data Integrity experience project is a plus.
  • Excellent writing skills for scientifically sound technical documents, instructions, validation
  • protocols and reports in English, French is an asset.
  • Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5,
  • 21 CFR part 11,).
  • Strong analytical thinking and problem-solving ability.
  • You are a strong team player, with excellent inter-personal communication skills.
  • You are used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Self-dependent way of working; taking ownership of assigned tasks; to plan and deliver according to agreed timelines.