Barcelona-Based CSV & GxP Compliance Consultant

PharmaX Solutions; Barcelona; On-site; EUR 45,000 - 65,000; Full time

Job summary

PharmaX Solutions is seeking a CSV Consultant to join our team in Barcelona, Spain. You will work closely with clients to ensure computerized systems meet GxP and regulatory requirements, performing CSV activities and supporting audits.

The role emphasizes data integrity, ALCOA+ principles, and collaboration with cross-functional teams to deliver practical compliance solutions in life sciences projects.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in CSV activities and validation.
• Knowledge of GxP regulations and guidelines (FDA, EU, ICH).
• Familiarity with documentation practices and ALCOA+.
• Experience with validated systems like TrackWise, Veeva Vault or similar.

Responsibilities

• Performing CSV activities and validation tasks in client projects.
• Ensure compliance with GxP regulations and industry standards.
• Support data integrity and ALCOA+ principles across systems.
• Prepare for and assist regulatory audits and inspections.
• Identify and manage validation and compliance risks.
• Support and improve Quality Management Systems (QMS).
• Collaborate with clients, technical, quality and business teams.
• Prepare and review validation and compliance documentation.

Skills

CSV knowledge

GxP compliance

Data integrity (ALCOA+)

Audits & inspections

Communication

Project management

Excel

Analytical thinking

Client collaboration

English (B2)

Education

Bachelor's degree in Life Sciences/Chemistry/Pharmacy/Biotechnology/IT/Engineering

Tools

TrackWise

Veeva Vault

ValGenesis

HP ALM

KNEAT

SAP

LIMS

MES

Job description

PharmaX Solutions is seeking a CSV Consultant to join our team in Barcelona, Spain. You will work closely with clients to ensure computerized systems meet GxP and regulatory requirements, performing CSV activities and supporting audits.

The role emphasizes data integrity, ALCOA+ principles, and collaboration with cross-functional teams to deliver practical compliance solutions in life sciences projects.