Are you an IT Quality thought leader, looking for an opportunity to work on Cell and Gene Therapy Systems?
SQA is working with a leading pharmaceutical company who needs additional bandwidth in their IT QA team. We are looking for an IT QA resource to support their GMP, GDP and GVP systems. This position will be responsible for supporting the Computerized Systems Quality and Management (CSQM) group working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement. This role will review and approve computerized system lifecycle documentation as well as provide GAMP, Part 11/ Annex 11, and data integrity expertise to key stakeholders.
- 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
Critical Success Factors include experience with the following:
- 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
Job ID: 2006-5895
SQA is an equal opportunity employer and supports workforce diversity.