06 oct
|
Rephine
|
Barcelona
GMP Lab Analyst | CSV Consultant
Join Rephine: Leading Life Sciences Quality Worldwide
At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, India and China, we support the Pharmaceutical, Biotech and Medical Device supply chains globally.
Who We're Looking For:
Are you a pharmaceutical or analytical laboratory professional with GMP experience looking to take your career into CSV consulting? Do you have hands-on experience operating laboratory equipment and working under quality standards in a regulated environment? If you are ready to grow into computerised system validation in a integral consultancy that invests in its people, we want you as our next GMP Lab Analyst & CSV Consultant (L3).
Your Role:
As an L3 CSV Consultant, you will contribute to validation projects in GxP-regulated environments, applying your pharmaceutical laboratory knowledge to support the validation of computerised systems used in lab and manufacturing settings.
You will work alongside experienced consultants who will guide your development while you build your CSV expertise.
Key Responsibilities:
• Contribute to the validation of computerised systems used in pharmaceutical laboratory environments (LIMS, ELN, laboratory instruments, analytical software)
• Prepare and review validation documentation including VMPs, URS, IQ/OQ/PQ protocols, traceability matrices and validation reports
• Apply your GMP laboratory knowledge to understand system requirements and ensure they meet regulatory standards
• Support deviation management, change controls and CAPA activities
• Collaborate with client laboratory teams, QA and IT to gather requirements and deliver validation activities on schedule
• Participate in client meetings and on-site laboratory visits as part of project delivery
• Actively develop your knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity guidelines.
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What We're Looking For:
📌 GMP Lab Analyst | CSV Consultant (Barcelona)
🏢 Rephine
📍 Barcelona