Bethany Reade Email & Phone Number

Auckland, Nz

Auckland, New Zealand

Project and Systems manager.SME in the companies AX dynamics system. Managed QPulse program and related document control team. Managed new product implementation.

 Ensure company QA System is maintained to ensure consistent manufacture and quality control of therapeutic xenotransplantation products in compliance with GMP, IANZ and other relevant regulatory standards. Maintain compliance with Good Manufacturing Practice (GMP) for the manufacture of Medsafe-licensed medicinal products. Maintain IANZ accreditation for molecular diagnostic laboratories. Ensure clinical trials infectious surveillance program meets relevant regulatory guidelines Manage Document Control/Stores Controller staff, including monitoring of KPI’s. Operational compliance with PIC/s to continue maintenance of Medsafe approval to manufacture therapeutic products. Audits deficiencies are addressed and documented. Products have had appropriate in-process QC testing and final product meets specifications prior to release. Required permits and licenses are maintained including controlled drugs licenses and MPI transitional facility status. License applications are completed and approved on time and in full Animal facilities are maintained in compliance with the 1999 NZ Animal Welfare Act. Maintain the systems of Change Control, deviations, CAPA, OOS, Risk Assessments and ensure they are performed as required and documented appropriately.  Internal audits are completed within specified timeframes according to schedule. External suppliers of critical inventory have been appropriately reviewed and approved by QA. Staff Training is conducted in accordance with GCP and GMP on time and in full. QC assays are validated and documented to GMP standard. Raw Materials are documented, quarantined and released according to requirements.

Auckland, New Zealand

 Monitor the compliance of manufacturing, QC and animal facility activities with the DOL Quality Assurance System. Maintain compliance with Good Manufacturing Practice (GMP) for the manufacture of Medsafe-licensed medicinal products. Provide QA support to the DOL animal facilities and assist them to meet relevant compliance. Provide support to the production team to ensure all medicinal products are manufactured in compliance with GMP, appropriate in-process testing is performed and final product meets specification prior to release. Complete internal and external audits to ensure regulatory guidelines are consistently met. Train staff in QA systems and GMP Authorized delegate for Head of QA duties  Corrective actions, non-conformances and related documentation are monitored to ensure timely completion. SOP updates are implemented and support for document review is provided.  Validation documentation is reviewed to ensure compliance with regulatory requirements. Data required for monitoring of manufacturing and quality control activities is compiled, analyzed and relevant data reported as required.  Corrective measures are tracked to ensure timely compliance. Required action items are followed and closed upon completion. Participate in LEAN activities and generates ideas for improvement. Strives to generate ideas for improvement in the Quality systems and documentation.

Auckland, New Zealand

Auckland