Senior CSV Validation & Data Integrity Lead Remote

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 46.800 - 57.200; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Remote work options

Tax assistance

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma invites a Global R&D QA, Senior Validation, Digital & Data Integrity Specialist to join our Quality Assurance team.

You will ensure state-of-control validation of software systems used in GXP processes and manage projects requiring CSV expertise. The role demands at least 5 years in computerized systems validation within the pharmaceutical industry, with deep knowledge of Data Integrity, CFR 21 Part 11, EU GMP Annex 11 and risk management.

Competenze

• Minimum 5 years of validation experience in the pharmaceutical industry.
• Excellent knowledge of activities necessary for Computer Systems Validation.
• Strong understanding of Data Integrity principles and risk management methods.

Mansioni

• Coordinate and supervise validation of computerized systems in the GxP environment.
• Draft validation plans, summaries and periodic reviews for software domains.
• Review URS, functional specs, qualification reports and software procedures.
• Manage changes, deviations and CAPAs related to software systems.
• Participate as technical expert in audits and with software suppliers/clinical service providers.
• Promote awareness of CSV and Data Integrity among personnel using software systems.
• Conduct and support training on procedures and regulations for software validation.
• Review or approve SOPs for software systems in line with regulations.
• Support Risk Assessment and Risk Management reporting for software quality aspects.
• Act as CSV point of contact during authority inspections.
• Support collection and assessment of QMS KPIs for the area.

Conoscenze

Validation of computerized systems

Data Integrity

Regulatory knowledge CFR 21 Part 11

EU GMP Annex 11

ICH E6

Risk Management techniques

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma invites a Global R&D QA, Senior Validation, Digital & Data Integrity Specialist to join our Quality Assurance team.

You will ensure state-of-control validation of software systems used in GXP processes and manage projects requiring CSV expertise. The role demands at least 5 years in computerized systems validation within the pharmaceutical industry, with deep knowledge of Data Integrity, CFR 21 Part 11, EU GMP Annex 11 and risk management.