Overview
On Site
Full Time
Skills
System Documentation
Test Plans
ROOT
Auditing
Inspection
Collaboration
Regulatory Compliance
Science
Computer Science
Life Sciences
Technical Writing
Quality Management
Computerized System Validation
GAMP
GMP
GxP
Data Integrity
Risk Assessment
Job Details
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.
- pply 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.
- 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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