Validation Specialist

We are a leader in technology services for companies in regulated industries with over 24 years of experience. We focus on life sciences, QA, validation, cloud systems, human capital management (HCM), and Salesforce. We support international companies in regulated industries including banking, finance, insurance, and pharmaceuticals.

• At least 2 years of experience working in a validation department.
• Experience with commissioning, calibration, and hot loop checks.
• Hands-on experience validating solutions based on the Dynamics 365 platform.
• Very good knowledge of regulations and regulatory requirements: EU GMP, FDA, and GAMP 5 guidelines.
• Knowledge of ALCOA+ principles.
• Practical knowledge of laboratory (QC) processes and experience implementing and validating LIMS-class systems.
• Understanding of cloud architecture and the specifics of validating SaaS systems, with particular emphasis on the Veeva Vault platform.

Nice to have:

• Knowledge of cleaning validation.

• Leading and overseeing validation projects, and defining and maintaining a consistent validation approach.
• Coordinating the validation and quality area: planning and supervising testing, system acceptance, and the creation of quality documentation.
• Supporting data migration strategy, analyzing user requirements (URS), and mapping business processes.
• Managing risks and issues, and responding quickly and effectively to unexpected technical problems.
• Preparing, reviewing, and approving validation documentation.
• Regular collaboration with the project team and participation in project meetings.