Responsible for ensuring compliance to International and Regional Quality change management requirements; managing life cycle of all site Quality Change Requests (QCRs); review of QCRs for completeness and accuracy; coaching of requestors through the change control process and resolution of deficiencies with the requests; facilitating impact assessment of the QCRs; manages routine Local Change Board (LCB) meetings; dispositioning
QCRs on behalf of the LCB.
1. Change Review Specialist (CRS): reviews all QCRs for completeness and accuracy (information is factual and objective without opinions, conjecture or exaggeration)
2. Works closely with the requestor of the QCR to develop and refine the information in the request
3. Liaises with functional groups (Regulatory Affairs, R&D, and Mfg) to assess the potential impact of the change on existing processes and products and the strategy for implementation of the change
4. Manages local change board (LCB) review and approval/rejection of all QCRs
5. Determines per NSOP guidance if QCRs should be elevated to Change Oversight Committee (COC) and, if elevated, coordinates with Maintenance of Business (MOB) coordinator and requestors to present changes to the COC
6. Determines if other sites are impacted and assures impacted sites are notified of the change
7. Performs approval of change requests on behalf of the LCB and monitors status of QCRs throughout the workflow steps.
8. Develops and implements change control and other QA system improvements
1. Procures documentation and data required for regulatory filings including new submissions, renewal, site registrations, and variations
2. Conducts QA review for documentation includes in filings
3. Procures samples for registration and quality analysis
4. Coordinates method transfer meetings
5. Provides support for completing deficiency responses to health authorities
6. Provides support for production model consolidation
7. Liaises with RA and Tampa site SME to assess the potential impact of changes
8. Coordinates compendial change notification meetings
Responsible for QCR workflow management for the Tampa site.
Internal Team; Regulatory Affairs (regional and international)
BA or BS in any interdisciplinary science or engineering field. NLT 5 years in a GMP facility. Proficiency in computer operation; ability to work independently and efficiently; good organizational and investigational skills; ability to follow detailed written procedures; able to handle multiple tasks simultaneously and prioritize accordingly; good communication skills, verbal and written; good analytical ability; ability to work well with others;
Good problem-solving skills; detailed-oriented.