Global R&D QA, Senior Validation, Digital & Data Integrity Specialist
Chiesi
Overview
As a Global R&D QA Specialist, you ensure controlled state and validation of software systems used in GXP processes. You lead validation projects for computerized systems and support audits, training, and risk management to uphold data integrity. You will collaborate across R&D functions to align CSV activities with regulatory expectations and continuous improvement. This role offers impact by safeguarding software quality in a fast-moving biopharma environment.
Retribuzione / Benefits
- annual bonus eligibility
- comprehensive benefits package
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
Responsabilità
- Coordinate and supervise validation of computerized systems in the GxP context
- Draft validation procedures, plans, summaries, and periodic reviews in the software domain
- Review and approve URS, functional specs, qualification reports, and software procedures
- Manage changes, deviations, and CAPAs related to software systems
- Participate as Technical Expert in internal/external audits of software suppliers and clinical service providers
- Promote awareness of CSV and Data Integrity among personnel involved with software systems
- Conduct and support training on software validation and Data Integrity regulations
- Review/approve SOPs related to software systems
- Support Risk Management as Risk Coordinator for software quality
- Act as CSV point of contact during authority inspections
- Support collection and assessment of QMS KPIs for the area
Requisiti fondamentali
- At least 5 years of experience in validation of computerized systems (CSV) in the pharmaceutical industry
- Excellent knowledge of activities for Computer Systems Validation
- Strong knowledge of European and U.S. quality regulations and guidelines (CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO; ICH E6, GAMP5 2nd Ed)
- Excellent understanding of Data Integrity principles
- Good knowledge of Risk Management techniques
- Fluent English
- Clear communication
- Training and knowledge sharing
- Cross-functional collaboration
- Computer Systems Validation (CSV)
- Data Integrity
- Regulatory compliance knowledge (CFR 21 Part 11, EU GMP Annex 11, ICH E6)
Offerta di lavoro pubblicata 2 giorni fa
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