CSV Consultant ( Barcelona, Spain)

CSV Consultant ( Barcelona, Spain)

11 oct
|
Pharmax Solutions
|
Barcelona

11 oct

Pharmax Solutions

Barcelona

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 communication and interpersonal skills
- Ability to manage multiple projects and priorities
- A collaborative, proactive and client-focused mindset

Education

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biotechnology, IT, Engineering or a related field

Languages

English: Strong working/technical proficiency (minimum B2 level)

Why PharmaX?

At PharmaX, you’ll have the opportunity to:

- Work on real-world projects within the pharmaceutical and life sciences industry
- Collaborate with international clients and cross-functional teams
- Develop your expertise in GxP, CSV, validation and digital compliance
- Work in a growing and collaborative environment
- Make a direct impact on quality, compliance and patient safety

If you're ready to take the next step in your CSV/GxP career , we’d love to hear from you.

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📌 CSV Consultant ( Barcelona, Spain)
🏢 Pharmax Solutions
📍 Barcelona

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