CSV Compliance Specialist

vor 1 Woche

Bubendorf, Basel-Land, Schweiz D-ploy Vollzeit

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.

We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer's IT productivity and contribute to the organization's success and value.

We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us

Tasks and Responsibilities
  • Create and deliver CSV documentation, including Validation Plans, Requirements Specifications, Test Protocols, and Summary Reports.
  • Ensure security and compliance solutions and projects comply with QA and CSV procedures and regulatory standards.
  • Collaborate with project teams to gather information and ensure accurate documentation.
  • Review and update CSV documents to reflect system and process changes.
  • Execute validation tests as necessary.
  • Train and support project teams on CSV documentation requirements.
  • Stay updated with CSV best practices and regulatory requirements.
  • Enable projects to comply with CSV requirements when using Agile project management methodology.
  • Coach colleagues on validation and qualification activities, supporting training for teams new to CSV compliance in projects.

Requirements

  • Bachelor's degree in computer science, IT, or a related field.
  • Minimum of 3 years of experience in delivering CSV compliance testing and documentation.
  • In-depth knowledge of Waterfall and Agile project management methodologies.
  • Strong experience in running CSV compliance activities for projects managed in Agile.
  • Comprehensive understanding of GMP regulations and guidelines applied in pharmaceuticals.
  • Exceptional documentation skills with a focus on detail and accuracy.
  • Ability to work independently and manage concurrent tasks.
  • Effective communication and team collaboration skills.
  • All candidates must provide a Criminal record (not older than 3 months)

Benefits

  • Broad range of activities, tasks, and projects
  • Flexible working conditions
  • Vouchers (B-day voucher, wedding, and new born surprise)
  • Fishing for Friends program – our referral program
  • Refreshments in the D-ploy office
  • Further development and professional advancement
  • Friendly and international working environment
  • Company-sponsored events
  • Competitive salary and various benefits

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