Katalyst Healthcares and Life Sciences
Senior Quality Validation Lead
Katalyst Healthcares and Life Sciences, Boston, Massachusetts, us, 02298
Responsibilities:
Understands regulations pertaining to the implementation and use of computerized systems in all GxP 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 computerized systems used in the GxP areas. Consults with QISM 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 and relevant GxP work experience. Proficiency in using Microsoft Office applications. 8-10 experience performing validation activities. 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.
Understands regulations pertaining to the implementation and use of computerized systems in all GxP 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 computerized systems used in the GxP areas. Consults with QISM 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 and relevant GxP work experience. Proficiency in using Microsoft Office applications. 8-10 experience performing validation activities. 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.