Possible locations
  • Bialystok
  • Bydgoszcz
  • Czestochowa
  • Gdansk
  • Gliwice
  • Katowice
  • Kielce
  • Cracow
  • Lublin
  • Lodz
  • Pila
  • Poznan
  • Rzeszow
  • Szczecin
  • Torun
  • Warsaw
  • Wroclaw
  • Remote work

Join our team working on a project for one of the largest pharmaceutical companies in the world and have an impact on the lives and health of more than 15 million patients! If you are interested in working with top-class scientists from Silicon Valley/Western Europe, and helping them to fight cancer and other difficult diseases by accelerating IT potential do not hesitate to apply!

Your main tasks as validator will include maintaining the quality of computerized systems regulated by pharmaceutical law throughout the software lifecycle as well as being Software Quality Assurance Coordinator for validated safety critical computerized systems.

Your role

  • Determine validation approach, identify deliverables needed or impacted by a project/enhancement or change for GXP computerized systems
  • Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance
  • Provide estimates and forecast validation activities for a project
  • Author validation plans/reports, review test plans/reports (and other deliverables) to assess and notify that system is ready to go life
  • Determine testing strategy, requirements, and acceptance criteria
  • Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
  • Coordinate and advise on all validation activities on a global level/organizational level for system/project

Your skills
  • 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment
  • Experience in authoring validation plans, reports, and deliverable registries
  • Experience in authoring or reviewing validation related deliverables, records, and other evidence
  • Experience in software development lifecycle processes (SDLC), models, and 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

Job no. 220524-1TSYX

Why Sii

Great Place to Work since 2015

it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas

Hundreds of fascinating projects

prestigious brands from around the world, long-term contracts and preferred partner status for many clients

Project suited to you

Do you want to change your career path? Is your project coming to an end? We’ll find you a new one! We have an app for this – Job Changer

Employment stability

revenue of EUR 225 M, no debts, since 2006 on the market

PLN 500 000 per year for your ideas

with this amount, we support the passions and voluntary actions of our workers

7 000 experts

Tech Communities and the best industry experts to learn from

Investment in your development

workshops, webinars, training platform, and technology blog – you choose

Great, comfortable offices

perfect place to work, integrate, have fun together, and celebrate successes

Open-minded and available management team

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

created by all Sii Power People

Attractive benefits package

private healthcare, benefits cafeteria platform, car discounts and more

Show more Show less
Possible locations
  • Bialystok
  • Bydgoszcz
  • Czestochowa
  • Gdansk
  • Gliwice
  • Katowice
  • Kielce
  • Cracow
  • Lublin
  • Lodz
  • Pila
  • Poznan
  • Rzeszow
  • Szczecin
  • Torun
  • Warsaw
  • Wroclaw
  • Remote work

Join our team working on a project for one of the largest pharmaceutical companies in the world and have an impact on the lives and health of more than 15 million patients! If you are interested in working with top-class scientists from Silicon Valley/Western Europe, and helping them to fight cancer and other difficult diseases by accelerating IT potential do not hesitate to apply!

Your main tasks as validator will include maintaining the quality of computerized systems regulated by pharmaceutical law throughout the software lifecycle as well as being Software Quality Assurance Coordinator for validated safety critical computerized systems.

Your role

  • Determine validation approach, identify deliverables needed or impacted by a project/enhancement or change for GXP computerized systems
  • Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance
  • Provide estimates and forecast validation activities for a project
  • Author validation plans/reports, review test plans/reports (and other deliverables) to assess and notify that system is ready to go life
  • Determine testing strategy, requirements, and acceptance criteria
  • Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
  • Coordinate and advise on all validation activities on a global level/organizational level for system/project

Your skills
  • 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment
  • Experience in authoring validation plans, reports, and deliverable registries
  • Experience in authoring or reviewing validation related deliverables, records, and other evidence
  • Experience in software development lifecycle processes (SDLC), models, and 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

Job no. 220524-1TSYX

Why Sii

Great Place to Work since 2015

it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas

Hundreds of fascinating projects

prestigious brands from around the world, long-term contracts and preferred partner status for many clients

Project suited to you

Do you want to change your career path? Is your project coming to an end? We’ll find you a new one! We have an app for this – Job Changer

Employment stability

revenue of EUR 225 M, no debts, since 2006 on the market

PLN 500 000 per year for your ideas

with this amount, we support the passions and voluntary actions of our workers

7 000 experts

Tech Communities and the best industry experts to learn from

Investment in your development

workshops, webinars, training platform, and technology blog – you choose

Great, comfortable offices

perfect place to work, integrate, have fun together, and celebrate successes

Open-minded and available management team

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

created by all Sii Power People

Attractive benefits package

private healthcare, benefits cafeteria platform, car discounts and more

Show more Show less

Join us

Personal information

Location of work *

Send your current CV *

or drag and drop your file here

Allowed extensions: DOC, DOCX, PDF (max 5MB)

Your message was sent successfully.

Thank you!

Find out more about Sii

Sorry, something went wrong and your message couldn’t be delivered.

Please refresh the page and try again.

Processing...

Do you have a friend looking for a new role?

Bring them to Sii and receive a bonus

Your data

Recommended person data

Recommended person CV *

or drag and drop your file here

Allowed extensions: DOC, DOCX, PDF (max 5MB)

Location of work*

TERMS AND CONDITIONS
Introduce your friend to Sii
If she/he joins us
You get up to PLN 8 000

Your message was sent successfully.

Thank you!

Find out more about Sii

Sorry, something went wrong and your message couldn’t be delivered.

Please refresh the page and try again.

Processing...

SUBMIT

Ta treść jest dostępna tylko w jednej wersji językowej.
Nastąpi przekierowanie do strony głównej.

Czy chcesz opuścić tę stronę?

Einige Inhalte sind nicht in deutscher Sprache verfügbar.
Sie werden dann auf die englische Sprachversion der Website weitergeleitet.

Möchten Sie fortsetzen?