Computer System Validation Lead
hace 2 días
Advanced Resource Managers is a global consulting firm that helps leading Pharmaceutical, Biotech, and Medical Device companies achieve their quality and compliance goals.
We are currently seeking a highly experienced Computer System Validation Lead to join our team in Barcelona. This role will involve leading validation projects for computerised systems, ensuring compliance with industry regulations, and working with cutting-edge systems to assess their compliance and readiness.
Salary: €80,000 - €100,000 per year, depending on experience, plus additional holiday entitlement and other benefits.
Responsibilities- Leading validation projects: Ensure compliance with industry regulations, including EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
- Assessing system compliance: Work with ERPs, eDMS, eQMS, LIMS, SCADA, EBR, and pharmacovigilance platforms to assess their compliance and readiness.
- Collaborating with clients: Deliver high-impact results while adhering to agreed timelines and standards.
Requirements:
- Bachelor's degree: In Chemistry, Engineering, or a related field.
- Experience: Proven experience in the pharmaceutical or life sciences industry, particularly in GxP compliance and computerised system validation.
- Language skills: Fluency in Spanish and English is essential.
Why Choose Us?
- Competitive compensation: A salary that reflects your experience, plus additional holiday entitlement and other benefits.
- Flexibility: Hybrid working options, flexible hours, and shorter Fridays.
- Global exposure: Opportunities to collaborate with a multicultural team and work on international projects.
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