QA Validation Specialist

3 weeks ago


Boston, United States Katalyst HealthCares & Life Sciences Full time

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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