Oferta pracy

Validation Lead

SII Sp. z o.o.O firmie

  • Częstochowa, śląskie

  • Ogłoszenie wygasło 16 dni temu
  • Rekrutacja zdalna
  • Praca zdalna
  • Specjalista (Mid / Regular)
In respect of recommendations concerning coronavirus to limit face-to-face meetings, we are open to conduct recruitment interviews online, using video-conference.
Validation LeadNumer ref.: 210429-OYKNH
Your role:

Join our team working on projects of one of the largest pharmaceutical companies in the world and have a real impact on the lives and health of more than 15 million patients! By implementing the projects of Sii's key, long-standing client, you will get the chance to develop in the field of R&D, clinical trials and global services. You will work based on Agile methodologies, using modern tools and technologies.


We will ensure the continuity of your employment, at the same time giving you the opportunity to change your project or project team at any time. You will be also offered regular in-house training and specialist workshops. Remote work, work at the office or flexible working hours – the choice is 100% yours.


Your tasks:

  • Determine validation approach, identify deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
  • Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
  • Provide estimates and forecast validation activities for a project
  • Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
  • Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
Your skills:
  • 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
  • Experience in leading validation for projects and systems maintenance, as well as in authoring validation plans, reports and deliverable registries
  • Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
  • Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
  • Fluent (written and spoken) English – we work in international teams and set ups


Why is it worth joining us?

  • Great Place to Work since 2015
    it's thanks to our workers' opinions that we get the title and implement new ideas
  • Dozens of fascinating projects
    for prestigious brands from all over the world, based on a variety of technologies
  • Employment stability
    Is your project coming to an end? Do you want to change it? We'll find you a new one! We have an application for this – Job Changer
  • Financial stability
    Revenue of EUR 200 m, no debts, preferred supplier status for many clients
  • Investment in your growth
    meetups, webinars, training platform and technology blog – you choose
  • 5 000+ experts
    to learn from and share your experience with
  • PLN 500 000 per year for your ideas
    with this amount, we support the passions and voluntary actions of our workers
  • Attractive benefits package
    private healthcare, MyBenefit platform, car discounts and more
  • Comfortable workplace
    Class A offices or remote work
  • Friendly management
    quick decision-making, we're all on a first-name basis
  • True values
    these are not empty words – we're guided by them every day
  • Fantastic atmosphere we're famous for
    created by all Sii Power People

Are you interested in this offer?

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