Validation Specialist
eConsulting
- Praca zdalna
Required Skills and Experience
- At least 2 years of experience working in a validation department.
- Commissioning, Calibration / Hot Loop Checks.
- Hands-on experience validating solutions based on the Dynamics 365 platform (D365 validation experience).
- 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.
We are looking for an experienced Validation Specialist to join our team and take full ownership of the end-to-end validation process across our projects. We are seeking a candidate with solid technical knowledge and a strong understanding of laboratory systems and cloud environments.
What We Offer
- Access to a benefits program: private medical care, sports card, and group insurance.
- English lessons with a dedicated teacher.
- Access to an extensive training library covering both soft and technical skills.
- Company events, competitions, and challenges.
Who We Are – in Brief
We are a leader in technology services for companies in regulated industries. We have delivered hundreds of projects for clients around the world and bring over 24 years of market experience, with a particular focus on areas such as life sciences, QA, validation, cloud systems, human capital management (HCM), and Salesforce.
Industry: We operate in the IT sector.
Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).
,[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. ] Requirements: Testing, D365, QC, QA Additionally: Sport Subscription, Private healthcare, English lessons, Integration events.