The Biopharmaceuticals Testing Laboratory (BioCTL) Quality Assurance Specialist (QA) will ensure that the BioCTL complies with all QMS and relevant regulatory standards in relation to data generation and laboratory testing and approval.
- Ensure the BioCTL complies with all QMS and relevant regulatory standards in relation to laboratory data generation and approval, maintain relevant GxP training compliance requirements, support delivery of training courses and relevant learning material and assure compliance with method SOPs by performing real time GEMBA/process confirmation during assay execution and LES data integrity pathway reviews.
- Initiate and coordinate deviation and change control notifications in the SAP system, complete CAPAs and change control tasks as required, participate in root cause analysis for deviations, customer and service complaints as QA representative as well as performing department's self-inspection (L1) and Audit Trail reviews, maintaining associated schedules and documentation.
- Ownership of quality systems (e.g. deviations, change controls), Control Printing, Reconciliation Process and site Curricula Review Process; including provision of metrics and report program trends on a periodic basis and review and initial approval of LI notifications in SAP system.
- Manage the archiving for all documentation both on and off-site. This includes maintaining the validated document register, organizing and filing paperwork in line with local procedures and requirements, as well as retrieving and returning archived documentation as required.
- Assist in the preparation for and participation in regulatory agency inspections, corporate, customer and monitoring L2 audits including audit readiness assessments as required.
- Provide support to the site Compliance team by performing activities such as; review and respond to Quality Alerts, maintenance of the GMP training schedule.
- Perform CDMS Local Administrator role for CDMS and support the BioCTL as the site contact for GMS CDMS and provide training for CDMS as required.
- Manage the BioCTL Records Retention Schedule and act as Records Champion.
- Compete administration activities as required.
Minimum Level of Education*
- Bachelor of Science
- required Significant experience working in a GMP regulated environment in a role directly related or supporting Quality or Manufacturing.
- Laboratory experience preferred.
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