Location
Wilson, NC | United States
Job description
The Principal QA Specialist role is a temporary role within the US Commercial Quality organization. The purpose of this role is to assure all activities associated with the post-site closure of the Sandoz Wilson, NC facility are maintained and within the established time-lines.
Major Accountabilities:
Annual Performance Quality Review (APQR)
responsibilities:
• Assure that all Sandoz Wilson APQRs are completed (i.e. fully approved) in accordance with the predefined schedule.
• Oversight of DHL for the retain inspection execution. Review of the retain inspection forms and provide the APQR retain inspection data to the QSC for the APQR.
• Provide all stability study information needed for the APQR to the QSC inclusive of MiniTab analysis.
• Provide support to the QSC in regard to data required for the APQR generation.
• Provide stability assessment evaluations in case of detection of adverse trends during the APQR stability calculation.
FDA Annual Reports
responsibilities: • Provide all LIMS stability reports to Regulatory Affairs for inclusion in the FDA Annual Reports in accordance with the predefined schedule.
• Provide support to RA for all requests as associated with legacy Sandoz Wilson manufactured batches (as needed)
Stability-related responsibilities as related to Sandoz Wilson manufactured products:
• Track all on-going stability studies at the different testing centers.
• Confirm all stability samples pull on-time and are tested within the required timeline (i.e. 30 days from pull for CRT; 15 days from pull for Client/INT)
• Upload released test results into the Wilson Labware LIMS instance (as needed).
• Approval of all final stability summary reports after the last time point is QC released; due 60 days after the last time point is released.
• Support risk assessments or investigation for any stability chamber excursions.
Complaint Investigation Support as related to Sandoz Wilson manufactured products:
• Write complaint investigations as related to Sandoz Wilson manufactured batches.
• Must be competent in reviewing Electronic Batch Records in the quality system, Labware LIMS, Trackwise, and QEM systems.
Investigation Support as related to Sandoz Wilson manufactured products:
• Provide quality assurance oversight of any OOS/OOT/OOE investigations associated with the analytical testing of Sandoz Wilson manufactured batches for stability-related issues at Sandoz Kalwe/CMOs.
Retain Management Program:
• Provide notification to DHL when retains are ready for destruction (1 year post expiry of the batch).
Supplier Quality Management Support:
• Support QAA, QRA, Audit support requests, UQAP planning, EMPO, etc..
• Support of customer requests as related to compliance documentation for Wilson produced batches.
Job tags
Salary
