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Computer System Validation Consultant
hace 3 semanas
Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries
?
PQE Group
has been at the forefront of these industries
since 1998
, with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas
.
Due to a constant growth, we are looking for a
Computer System Validation Consultant
to join our team in
Barcelona
or
Madrid, Spain.
This is a hybrid role (
2 days working from home
) and requires
strong Spanish language skills
at a professional level.
Responsibilities
include, but are not limited, to the following:
- Support in Computer System Validation (CSV) activities:
Contribute to the execution of CSV projects, ensuring alignment with GxP requirements, 21 CFR Part 11, EU Annex 11, and applicable guidelines. - Preparation of validation documentation:
Assist in drafting and reviewing technical documents such as validation plans, protocols (IQ/OQ/PQ), reports, and risk assessments. - Execution of testing activities:
Participate in protocol execution, test result documentation, and deviation management as needed. - Support in risk assessments:
Collaborate in collecting information, performing preliminary risk analyses, and defining mitigation actions. - Cross-functional collaboration:
Work closely with IT, Quality Assurance, and other business functions to ensure proper implementation of compliance requirements. - Regulatory awareness:
Stay informed about relevant regulations and industry best practices related to computer system validation. - Client support:
Provide operational and consulting support to clients during CSV activities.
Requirements:
- Bachelor's or Master's degree in
Scientific or Technical disciplines
(Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.). - 1–3 years
of experience in the
Pharmaceutical industry
or in a related validation/qualification role. - Basic to intermediate understanding of
GxP regulations
,
21 CFR Part 11
,
EU Annex 11
, and other compliance requirements. - Native-level Spanish (mandatory)
and good command of
English
(B1–B2). - Familiarity with
GxP-regulated computer systems
, test management tools, and CSV-related tools. - Strong skills in
technical documentation
preparation and updating. - Good
organizational skills
, teamwork attitude, problem-solving mindset, and motivation to grow in the
CSV consulting
field.
Location:
Barcelona or Madrid, Spain
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the
opportunity to work on international projects
, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a
rewarding and exciting career
, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
