Oferta pracy

Validation Lead

SII Sp. z o.o.O firmie

  • Lublin, lubelskie

  • Ważna jeszcze 15 dni
    do: 01 lip 2021
  • Rekrutacja zdalna
  • Praca zdalna
  • Umowa o pracę, Kontrakt B2B
  • Pełny etat
  • Specjalista (Mid / Regular)
Validation Lead
Lublin
In respect of recommendations concerning coronavirus to limit face-to-face meetings, we are open to conduct recruitment interviews online, using video-conference.

Your role:

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 while allowing you 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.


Responsibilities:

  • 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 assess 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:

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 the 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 setups


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?

Do you have a friend looking for a new role?
Bring them to Sii and receive a bonus
 Introduce your
friend to Sii
 If she/he
joins us
 You get
up to PLN 8 000
 
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.: 210601-Z45ID
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 while allowing you 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.


Responsibilities:

  • 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 assess 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 the 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 setups


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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