11 oct
|
Pharmax Solutions
|
Cataluña
11 oct
Pharmax Solutions
Cataluña
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
📌 Csv Consultant (Cataluña)
🏢 Pharmax Solutions
📍 Cataluña