We're Hiring: CSV Consultant | PharmaX Solutions

Location: Barcelona, Spain
Are you passionate about Computerized System Validation (CSV), GxP compliance and data integrity
?
Do you enjoy working directly with clients and solving complex challenges in the life sciences industry?
PharmaX Solutions is looking for a CSV Consultant
to join our growing team and work on exciting projects across the pharmaceutical and life sciences sector.
What you'll do
As a
CSV Consultant
, you will work closely with clients and cross-functional teams to ensure that computerized systems and processes meet applicable
GxP and regulatory requirements
.
Your responsibilities will include:
Performing
Computerized System Validation (CSV)
activities
Ensuring compliance with
GxP regulations and industry standards
Supporting data integrity
and
ALCOA+
principles
Preparing for and supporting
regulatory audits and inspections
Identifying and managing compliance and validation risks
Supporting and improving Quality Management Systems (QMS)




Working with clients to understand their needs and develop practical compliance solutions
Collaborating with technical, quality and business teams
Preparing and reviewing validation and compliance documentation
What we're looking for
You bring
1–5 years of experience
in one or more of the following areas:
Computerized System implementation, Validation and change control
Validation of complex systems such as MES, SAP, LIMs.
GxP-regulated environments
You should also have:
Good knowledge of
GxP regulations and guidelines
, including FDA 21 CFR Parts 11, 210 & 211, EU GMP, ICH, GAMP 5 and ISPE
Understanding of
Good Documentation Practices (GDP)
and
ALCOA+
principles
Experience or familiarity with GxP systems such as
TrackWise, Veeva Vault or similar platforms
Familiarity with validation tools such as HP ALM, KNEAT or ValGenesis
Good working knowledge of Microsoft Office
, particularly Excel, Word and PowerPoint
Strong analytical and problem-solving skills
Excellent

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