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 PowerPoin
📌 CSV Consultant (Barcelona)
🏢 Pharmax Solutions
📍 Barcelona
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