GxP Validation Specialist (Warsaw)

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MidOn-site·WarszawaFull-time

#465115·Dodano 4 dni temu·3

Źródło: nofluffjobs.com

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Tech Stack / Keywords

CSV

Podsumowanie oferty

Lead and support GxP validation activities for a data platform. Provide validation oversight for regulated data products, transformations, 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.

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 activities.
Support the creation and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
Prepare qualification reports and validation evidence.
Support validation activities within 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.

Benefity

Training budget.
Private healthcare.
Multisport subscription.
Integration events.
Mental health support.
Referral program.
Canteen.
Free snacks and beverages, including tea and coffee.
In-house trainings.
In-house hack days.

Dofinansowanie szkoleń

Opieka zdrowotna

Karta sportowa

Spotkania integracyjne

Firmowa stołówka

Darmowe przekąski

Napoje w biurze

Szkolenia wewnętrzne

Inne informacje

Work from the European Union region and a work permit are required.

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