Bioinformatics & Software Validation Consultant @Thessaloniki

Tasks

• Advise on regulatory compliance
• Create and maintain validation deliverables
• Design and execute validation programs
• Develop validation strategies for GxP systems
• Guide and support computer system validation and software assurance
• Lead computer system validation initiatives
• Perform risk assessments for validation
• Translate regulatory requirements into validation plans and test protocols

Perks/Benefits

• Buddy onboarding
• Exclusive discounts
• Extra days of leave
• Flexible well-being programs
• Flexible working arrangements
• Hybrid working model
• Mobile phone
• Parental allowances
• Private medical health insurance plan
• Sponsored learning platforms
• Ticket restaurant card
• Travel for training

Skills/Tech-stack

21 CFR Part 11 | Annex 11 | CFR Part 11 | Computer system | Computer system validation | ERP | FDA 21 CFR | FDA 21 CFR Part 11 | GAMP 5 | GxP | IQ/OQ | IQ/OQ/PQ | IT Quality | LIMS | OQ PQ | Part 11 | Regulatory Compliance | Risk Assessment | SDLC | Software Assurance | System validation | Test Protocols | Traceability matrix | Validation planning