Senior Quality Validation Lead
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Boston, MA 02115
Description:
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.
- 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.