QA Validation Specialist - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
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.
- 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
Source : Katalyst Healthcares & Life Sciences