GxP CSV Specialist .Healthcare
- Warszawa, mazowieckie
- Stała
- Pełny etat
- Bachelor’s or Master’s degree in Life Sciences, Information Systems, Engineering, or a related field.
- 7+ years of experience working in GxP-regulated environments, with direct responsibility for Computer System Validation.
- Strong working knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and other regulatory guidance (e.g., FDA, EMA).
- Experience writing validation documentation and leading validation efforts for enterprise systems (e.g., LIMS, EDMS, ERP, CTMS, eTMF).
- Familiarity with SDLC methodologies, change control, and quality management systems (QMS).
- Ability to work independently and manage multiple validation projects simultaneously.
- Experience with cloud-based SaaS solutions subject to GxP requirements.
- Prior involvement in regulatory inspections (e.g., FDA, MHRA) or audit preparation.
- Working knowledge of data integrity principles and ALCOA+ framework.
- Certification in CSV, QA, or GxP compliance (e.g., ISPE, PDA).
- Act as a validation lead or advisor for computer systems used in GxP-regulated environments (e.g., LIMS, ERP, MES, eQMS, eTMF).
- Define and document validation strategy, scope, and deliverables in accordance with GAMP 5 and risk-based validation approaches.
- Collaborate with IT, QA, and business stakeholders to ensure systems meet compliance and business requirements.
- Write and review validation documentation, including URS, FRS, Risk Assessments, IQ/OQ/PQ, traceability matrices, and validation reports.
- Ensure systems comply with 21 CFR Part 11, Annex 11, and relevant GxP standards.
- Participate in vendor assessments and audits, ensuring third-party systems are appropriately validated.
- Review and align workflows to clinical trial protocols and commercial SOPs.
- Define and review QA checkpoints and quality gates.
- Ensure alignment with CoI/CoC processes, patient safety, and data integrity.
- Support URS and risk assessment development for validation.
- Guide GxP-compliant documentation and system implementation.
- Collaborate with IT and product teams on audit trail and logging requirements.
- Support test script review from a compliance standpoint.
- Represent QA during inspections and internal audits.
- Define deviation and change management workflows.
- Provide expert input for training, onboarding, and digital QA controls.
- Excellent documentation and organizational skills.
- Strong communication and stakeholder engagement abilities.
- Detail-oriented mindset with a strong sense of ownership.
- Ability to balance regulatory compliance with pragmatic business needs.
- Continuous learning and career growth opportunities
- Professional training and English/Spanish language classes
- Comprehensive medical insurance
- Mental health support
- Specialized benefits program with compensation for fitness activities, hobbies, pet care, and more
- Flexible working hours
- Inclusive and supportive culture