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CSV Consultant

PQE POLAND sp. z o.o.

  • Subcarpathia

    Subcarpathia
  • offer expired 4 months ago
  • contract of employment, B2B contract
  • full-time
  • specialist (Mid / Regular), senior specialist (Senior)
  • hybrid work
  • remote recruitment

Your responsibilities

  • Resolution of fundamental Computer System Validation compliance issues on assigned projects

  • Writing, reviewing and executing computer validation documentation

  • Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)

  • Preparation of project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP

  • Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP

Our requirements

  • At least 2 years of experience in Computer System Validation

  • English: full proficiency (any additional language will be considered a plus)

  • Availability to travel domestically and internationally up to 70%

  • Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11, …)

  • Ability to work as a team player in a consulting environment

  • Excellent communication skills

What we offer

  • Development opportunities

  • Project-based work

  • Competitive basic salary

  • Attractive travel bonuses

  • Multisport card

  • Various forms of employment

  • Possibility of remote work (depending on the project)

  • Work tools (mobile phone, laptop)

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • remote work opportunities

  • integration events

  • business apartment

  • opportunity to obtain permits and licenses

  • travel bonuses

PQE POLAND sp. z o.o.

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 900 employees all over the world (Europe, Asia and the Americas) and 25 subsidiaries, joining PQE means join a multicultural and challenging company in which you will be not only involved in international projects but you'll also have the chance to get in touch with colleagues from all over the world.

For more information, visit our web page at www.pqegroup.com.

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