USA - Country Quality Specialist

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.