Related skills
csv qms sops capa cgmp📋 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.
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