CSV Consultant

We’re Hiring: CSV Consultant | PharmaX Solutions| Location: Copenhagen, Denmark 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:

• Supporting 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 Validation
• Regulatory Compliance
• Quality Assurance
• Validation
• 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 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 ALM/validation tools such as KNEAT, HPQC 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, Pharmacy, Biotechnology, IT, Engineering or a related field Languages English: Strong working/technical proficiency Danish: Strong working/technical proficiency 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. Apply now and join PharmaX Solutions.