GxP Validation Specialist (Warsaw)

Brak informacji o wynagrodzeniu

NieokreśloneOn-site·WarsawFull-time

#465301·Dodano 4 dni temu·0

Źródło: Xebia

Aplikuj teraz

Tech Stack / Keywords

GxPCSVIQ/OQSOPDatabricksKneatAWS Azure GCP Snowflake

Podsumowanie oferty

The GxP Validation Specialist will lead and support validation activities for a data platform. The work includes qualification documentation, IQ/OQ protocols, change control, and validation oversight for regulated data products and reporting solutions.

Wymagania

Experience working in GxP-regulated environments.
Hands-on experience with computer system validation (CSV) or equivalent validation frameworks.
Experience creating and maintaining validation and qualification documentation.
Knowledge of IQ/OQ execution and qualification reporting.
Understanding of change control, risk assessment, and validation lifecycle management.
Familiarity with SOP creation and maintenance.
Experience working with quality and compliance stakeholders.
Strong documentation, communication, and organizational skills.
Ability to operate effectively in cross-functional teams.
Strong attention to detail and regulatory compliance requirements.
Work from the European Union region and a work permit are required.

Nice to have:

Experience validating cloud-based platforms and data solutions.
Experience with Databricks or modern data platforms.
Familiarity with validation management tools such as Kneat.
Experience supporting GxP analytical or reporting environments.
Knowledge of data governance and regulated data processing practices.
Experience in large-scale data modernization or migration programs.
Understanding of platform qualification automation and evidence-as-code approaches.
Experience supporting audits, inspections, or regulatory reviews.

Obowiązki

Lead and support GxP validation activities for the data platform.
Co-author validation and qualification documentation, including SOPs and validation deliverables.
Prepare and maintain qualification documentation and traceability records.
Contribute to risk assessments and validation planning.
Support the creation and execution of IQ/OQ protocols.
Prepare qualification reports and validation evidence.
Support validation activities in regulated systems and documentation repositories.
Ensure platform changes are assessed and managed through formal change-control processes.
Support requalification activities triggered by platform configuration changes.
Collaborate with platform engineers, architects, data engineers, quality teams, and business stakeholders.
Provide validation oversight for regulated data products, transformations, and reporting solutions.
Support inspection readiness, audit support, and compliance-related activities.
Participate in knowledge-transfer and operational handover activities.

Inne informacje

Work from the European Union region and a work permit are required.
Recruitment process: CV review, HR call, interview, client interview, and decision.

Xebia sp. z o.o.

113 aktywnych ofert

Zobacz wszystkie oferty

Aplikuj teraz