Corporate QA – (CSV) Specialist
20 hours ago
Girona
We’re supporting a well-established biologics pharmaceutical organisation based in Catalonia, Spain, currently undergoing a significant expansion across its manufacturing and quality operations. This position offers a strong mix of on-site collaboration (typically 1–2 days per week) with flexible remote working, and sit within highly regulated GMP environments across both manufacturing and corporate quality functions. This role sits at the intersection of Quality Assurance, IT systems, and regulatory compliance, ensuring computerised systems remain validated, compliant, and fit for purpose throughout their lifecycle. Typical systems include LIMS, QMS, MES, ERP (such as SAP), and electronic document management platforms. Key responsibilities: • Ensuring validation and compliance of computerized systems in GMP environments, • Supporting lifecycle management of regulated digital systems, • Driving CSV activities across cross-functional teams, • Maintaining audit readiness and documentation control What we’re looking for: • QA experience with exposure to CSV or validated systems, • Strong knowledge of GMP, validation, audits, and documentation control, • Confident communicator across IT, QA, and business stakeholders, • Scientific or technical degree background, • Strong Microsoft Office and Windows proficiency This role offer the chance to join a growing international organisation at a pivotal stage of expansion, with strong development opportunities across quality, validation, and corporate systems.