¿Tiene lo que se necesita para triunfar? La siguiente información debe ser leída atentamente por todos los candidatos.
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. xghoner
- 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
📌 CSV Consultant (Barcelona)
🏢 Pharmax Solutions
📍 Barcelona
Postulate a este anuncio
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.