Principal Quality Specialist
The Principal QA Specialist role is 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. Principal Quality Specialist Recommended Skills Manufacturing Risk Analysis Quality Management Research Laboratory Information Management Systems Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3v6s477zxh7t9tbwh0', 'ExternalApply-j3v6s477zxh7t9tbwh0'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
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. Principal Quality Specialist Recommended Skills Manufacturing Risk Analysis Quality Management Research Laboratory Information Management Systems Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3v6s477zxh7t9tbwh0', 'ExternalApply-j3v6s477zxh7t9tbwh0'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
