Senior CSV & Data Integrity Specialist — Remote Options

Biopharma Careers; Parma; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Remote work options

Tax assistance for foreigners

Descrizione del lavoro

Chiesi in Parma, Italy, seeks a Global R&D QA, Senior Validation, Digital & Data Integrity Specialist to maintain validated software systems in a GxP context and support related audits.

You will lead computerized system validation, draft plans and reviews, and ensure data integrity across regulatory requirements. The role includes training, risk management tasks, and collaboration with internal teams.

Competenze

• At least 5 years of experience validating computerized systems (CSV) in the pharmaceutical industry.
• Excellent knowledge of all activities necessary for Computer Systems Validation.
• Strong knowledge of CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO; ICH E6, GAMP5.
• Excellent understanding of Data Integrity principles.
• Good knowledge of Risk Management techniques.

Mansioni

• Coordinate and supervise validation of computerized systems (CSV) in the GxP environment.
• Draft validation plans (VPP), summaries (VSR), and periodic validation reviews (PVR).
• Review URS, functional specs, qualification reports, and software procedures.
• Manage changes, deviations, and CAPAs related to software systems.
• Participate as a Technical Expert in audits, including supplier and clinical service provider audits.
• Promote awareness of CSV and Data Integrity among personnel.
• Conduct and support training related to software validation and Data Integrity topics.
• Review or approve SOPs related to software systems.
• Support Risk Coordinator activities for software quality (risk reports).
• Act as the CSV point of contact during authority inspections.
• Assist in collecting and assessing QMS KPIs.

Conoscenze

CSV validation

Data Integrity

Regulatory knowledge

Risk management

Quality systems

English fluency

Descrizione del lavoro

Chiesi in Parma, Italy, seeks a Global R&D QA, Senior Validation, Digital & Data Integrity Specialist to maintain validated software systems in a GxP context and support related audits.

You will lead computerized system validation, draft plans and reviews, and ensure data integrity across regulatory requirements. The role includes training, risk management tasks, and collaboration with internal teams.