QA Validation Specialist
3 weeks ago
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.
Identifies and escalates areas of risk or non-compliance to manager / leadership team..
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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