18 sep
|
Oxford Global Resources
|
Cequeliños
18 sep
Oxford Global Resources
Cequeliños
Computerized Systems Validation (CSV) Specialist Barcelona | Pharmaceutical Industry | Hybrid
Are you passionate about quality, compliance, and digital transformation within highly regulated environments?
We are looking for an experienced Computerized Systems Validation (CSV) Specialist to join a leading international pharmaceutical company and play a key role in ensuring that critical GxP computerized systems remain compliant, reliable, and inspection-ready throughout their lifecycle.
As a CSV Specialist, you will act as a trusted expert supporting validation activities across manufacturing, quality, laboratory, and business systems. Leading validation projects for computerized systems from implementation through retirement.
Ensuring compliance with GMP regulations, Data Integrity requirements, Annex 11, and 21 CFR Part 11.
Managing validation-related deviations, CAPAs, and change controls.
Collaborating with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams.
Driving continuous improvement initiatives and supporting digital transformation programmes.
Previous experience in Computerized System Validation within a pharmaceutical, biotechnology, medical device, or other regulated environment.
Strong knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.
Experience validating GxP systems such as MES, LIMS, QMS, ERP, SCADA, laboratory systems, or manufacturing applications.
Opportunity to work with cutting-edge digital and automated systems.
Exposure to high-impact projects supporting pharmaceutical manufacturing and quality operations.
Strong focus on professional development and continuous learning.
Interested in helping shape the future of compliant digital systems in the pharmaceutical industry?
📌 Validation Consultant | Pharma - Hybrid (Cequeliños)
🏢 Oxford Global Resources
📍 Cequeliños