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QA Validation Specialist - Boston, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Develops understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas.
Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
Reviews and approves system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas.
Consults with CSQM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
Participates in performing Periodic Review activities of Computerized Systems
Provide support to regulatory inspection preparedness activities as needed.
Experience performing Infrastructure Qualification activities.
Requirements:
Bachelor's degree required.
Over 5+ years of GxP work experience, performing Quality Assurance function related to Computerized Systems / Infrastructure
Proficiency with regulations related to FDA / MHRA regulations.
Use of computerized quality management systems
Experience with validation of Enterprise / Lab Computerized Systems.
Quality metrics, dashboards, analysis, and improvement programs
Knowledge of GAMP and Agile validation lifecycle and methodologies
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