14 set - Emilia-Romagna
Chiesi
OverviewAs 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 / Benefitsannual premio eligibility
comprehensive benefits package
pension
private medical insurance
wellbeing programme
flexible benefits programme
ResponsabilitàCoordinate 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 fondamentaliAt 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)
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