GMP Lab Analyst to CSV Consultant - Remote/Hybrid

Rephine

Barcelona

Hybrid

EUR 45,000 - 65,000

Full time

39 hours ago

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Benefits offered by this job

Annual bonus

Hybrid work

Travel for client sites

Birthday card

Team building events

Global project exposure

Job summary

Rephine, a leading Life Sciences quality consultancy, seeks an L3 CSV Consultant to support validation of computerised systems in GMP environments. You will bring hands-on laboratory experience and regulatory know-how to client projects across pharmacy, biotech and medical devices sectors.

You will work with a senior CSV Director and a team of experts, expanding your expertise in GAMP 5, 21 CFR Part 11, and data integrity while delivering on-site and remote validation activities across Europe.

Qualifications

Must have hands-on GMP/GxP lab experience and regulatorily compliant practice.
Experience with laboratory instruments (HPLC, spectrophotometers, balances) and related software.

Responsibilities

Contribute to validation of computerised systems in GMP environments (LIMS, ELN, lab instruments, analytical software).
Prepare and review validation documents (VMPs, URS, IQ/OQ/PQ protocols, traceability matrices, validation reports).
Apply GMP knowledge to ensure systems meet regulatory standards.
Support deviation management, change controls and CAPA activities.
Collaborate with client labs, QA and IT to gather requirements and deliver on schedule.
Participate in client meetings and on-site lab visits as part of project delivery.
Develop knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity.