Quality Assurance CSV Engineer at ClinChoice

📋 Description

• Act as Process owner for computer systems validation management (local applications).
• Maintain Validation Master Plans up-to-date and ensure timely execution.
• Review and approve CSV documents (SOPs, requirements, plans, tests) for compliance.
• Collaborate with IT/engineering teams to introduce new systems while guarding cGMP.
• Participate in Change Management and address deviations during qualification/validation.
• Prepare for system audits and inspections; act as CSV spokesperson during audits.

🎯 Requirements

• Bachelor’s Degree or equivalent.
• Knowledge of cGMPs and GMP directives (21CFR11, 21CFR211).
• Knowledge of GAMP and IT infrastructure validation.
• Knowledge of software development and testing processes.
• Knowledge of quality auditing and quality metrics.
• Experience with pharma IT systems (PLCs, MES, LIMS) and test tools (qTest, KNEAT).

🎁 Benefits

• Global CRO with strong career development.
• Focus on quality and professional growth.
• Supportive cross-functional team environment.
• On-site role with client-facing projects.
• Training and continuous learning opportunities.