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Norgine

European specialty pharma focused on gastroenterology

CSV Analyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeDreux, FranceNo salary listedIn-person

About the Job

Requirements

  • Significant experience in computer system validation (CSV) in a regulated environment, ideally pharmaceutical.
  • Good knowledge of GxP, GAMP5, and quality systems.
  • Experience in application support and/or IT project management.
  • Professional proficiency in English.

Responsibilities

  • Gather business needs and analyze processes to identify opportunities to improve and automate systems.
  • Provide application support, manage incidents, and coordinate between business, IT, and service-provider teams.
  • Participate in IT system development, deployment, and validation projects for GxP systems.
  • Ensure system regulatory compliance through quality documentation management, including SOPs, URS, RTM, Change Control, periodic reviews, and deviations.
  • Keep IT system documentation and inventory up to date.
  • Train and support key users (SMEs) and support teams.
  • Contribute to continuous improvement of IT processes and business continuity.

About the Company

Norgine

European specialty pharma focused on gastroenterology

Norgine is a European specialty pharmaceutical company that develops, markets, and distributes prescription medicines for gastroenterology. Its products, such as MOVICOL, work as osmotic laxatives by drawing water into the stool to soften it and increase bowel movements, and are sold across Europe. The company distinguishes itself with a long, family-led history and deep GI expertise, now backed by Goldman Sachs Asset Management’s private equity arm to pursue growth through acquisitions and new product development. Its goal is to expand its GI-focused portfolio and strengthen its European market position through strategic acquisitions and new therapies.

Company size
1,001-5,000
Company stage
Acquired
Total funding
Not listed
Headquarters
Amsterdam, Netherlands
Founded
1906

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