Assignment Description
We are looking for an experienced Quality Manager IT
What You Will Work On
- Ensure IT compliance for computerized systems and IT infrastructure
- Review and approve risk assessments, qualification, and validation documentation
- Review change controls, deviations, and periodic system reviews
- Ensure compliance with GMP, GxP, SOPs, and internal quality requirements
- Support Computerized System Validation (CSV) activities
- Participate in IT compliance, qualification, and validation projects
- Provide QA support for IT projects and system changes
- Ensure data integrity principles are applied across IT systems
- Maintain and update the inventory of computerized systems
- Collaborate with QA, IT, Validation, Infrastructure, and Business stakeholders
- Support continuous improvements in IT quality, security, availability, and compliance
- Contribute to regulatory inspections and audit readiness
- Review technical documentation to ensure regulatory compliance
- Support quality activities throughout the system lifecycle
What You Bring
- Experience working in IT Compliance within the pharmaceutical, biotech, or other GxP-regulated industries
- Strong understanding of Computerized System Validation (CSV)
- Experience reviewing qualification and validation documentation
- Knowledge of GMP, GxP, and pharmaceutical quality systems
- Strong understanding of Data Integrity principles (ALCOA+)
- Experience with change control, risk assessments, and periodic reviews
- Experience supporting QA and validation activities for computerized systems
- Excellent communication and stakeholder management skills
- Pragmatic, solution-oriented, and collaborative mindset
- Flexible with a proactive approach to quality and compliance
If this sounds interesting, please send your CV to cv@veritaz.se
