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Roche Polska
Roche Polska
location iconLocations: Poznań
level iconLevel: specialist

What is Roche?

Founded in 1896
Employs over
90,000 people
Helps millions
of patients
Innovative
pharmaceuticals
and diagnostics

We are the IT center for Roche - a company in top 10 biggest R&D spenders worldwide.
We do #Code4life creating innovative software that helps doctors, patients and scientist around the world.

Senior IT Professional - Validation

Location: Poznań

Senior IT Professional - System Validator who will innovate healthcare

We are the IT centre for Roche - a company in top 10 biggest R&D spenders worldwide.

We do #Code4life creating innovative software that helps doctors, patients and scientists around the world.

Are you self-starter and team spirit oriented? Are you able to align meticulous approach with lean and agile way of thinking? If yes, we are waiting for you! As Senior IT Professional - Validation you will provide Software Development Lifecycle oversight to a multicultural team supporting various computerized systems. You will be responsible for guiding the project and business team to deliver systems in compliant manner and review software documentation according to EU and FDA guidance. You will support the team in the development and approval of computerized systems requirements in accordance with guidance and policy documents as well as lead audit preparations. What is more, you can be the author of innovative validation approach. At this position we expect you to develop/audit new processes or improve existing ones.

Required experience & qualifications:

  • Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry

  • 3+ years experience in IT & Software Validation, preferably in pharma environment (authoring or reviewing test/validation plans, system design documents, quality maintenance and support of regulated applications)

  • Practical knowledge of Computerized System Validation (CSV), Quality System Regulations, ISO 13485 Quality Standards and 21 CFR Part 11, 820.

  • Stakeholders management

  • Fluency in English

Very nice to have:

  • Knowledge of ISO 14971, ISO 17025

  • Lean and Agile project approach

Key responsibilities:

  • Driving computer system validation activities for business area/project/program

  • Planning and executing validation strategy, audit readiness, CAPA activities for IT systems

  • Working with management to achieve systems’ validation status through risk-based approach

  • Maintaining validation lifecycle of GxP computerized systems (Validation and Test Planning/Reporting)

  • Facilitating CSV and operational processes trainings for IT and business

  • Providing guidance on testing, validation and documentation to project managers, IT project teams, business teams and internal validation team

  • Working closely with 3rd party contractors

  • Providing full support by sharing expertise and knowledge to internal stakeholders

We offer:

  • salary range: 10000-13000 PLN gross/ month

  • dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths etc.)

  • a workplace that supports innovation and new ideas

  • attractive benefits & relocation package

  • work in a modern, cool office <link>

Interested?
...The next step is yours
We reserve the rights to reply only to chosen applicants.

Roche is an equal opportunity employer. We care about inclusion in terms of gender, age, race, skin colour, nationality, religion, marital status, sexual orientation, background, physical or mental disabilities and on every other grounds. Applying for our position, we assure you that we will assess your application solely on the basis of your competencies.

Details

  • iconIT
  • iconPoznań, wielkopolskie

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