Job Description

Responsibilities:

• Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance.

• Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables).
• Update existing validation deliverables and procedures in collaboration with the system owners.
• Apply ALCOA+ principles to validation deliverables and quality management system records.
• Support in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Support system audit/inspection preparation and execution as CSV subject matter expert.
• Complete or orchestrate timely completion of post-audit action items.
• Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
• Support system periodic reviews according to company procedures.
• Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
• Requirements:
• Education Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
• Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
• Good understanding of the ISA-95 models. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
• Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
• Good understanding of system and data risk assessment concepts.

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