01 oct
|
Rephine
|
Cataluña
Join Rephine Barcelona: 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 passionate about building your career in CSV consulting within the Pharma and Life Sciences sector? Do you thrive in dynamic environments, eager to grow technically, take ownership of your work and contribute to real impact? If you're excited by the challenge of validating computerised systems in a integral consultancy with the highest quality standards, we want you as our next CSV Consultant (L3) in Barcelona.
Your Role
As an L3 CSV Consultant, you will be an active contributor to validation projects, working alongside experienced consultants and under the guidance of senior team members. You will develop your expertise across a wide range of GxP computerised systems while building the autonomy and technical depth that defines a Rephine consultant.
Key Responsibilities
CSV Project Execution
- Contribute to the validation of computerised systems (ERP, LIMS, eQMS, eDMS, SCADA, laboratory systems) in GxP-regulated pharmaceutical environments.
- Prepare and review validation documentation including VMPs, URS, IQ/OQ/PQ protocols, traceability matrices and validation reports.
- Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5 and Data Integrity guidelines.
Quality & Compliance
- Support deviation management, change controls and CAPA activities.
- Contribute to supplier audits and compliance assessments under senior supervision.
- Maintain audit-ready documentation at all times.
Client & Team Collaboration
- Work closely with cross-functional client teams (QA, IT, business owners) to gather requirements and deliver validation activities on schedule.
- Participate in client meetings and on-site visits as part of project deliv
📌 Validation Software Consultant | GxP (Cataluña)
🏢 Rephine
📍 Cataluña