Catherine Orr Email & Phone Number

Macquarie Park, Nsw, Au

Sydney, New South Wales, Australia

Sterile Biotechnology manufacturing.Plasma fractionation.Deviations Investigations, Change Controls and CAPAs.EDMS implementation. Team & Project management. Process improvements.Auditing.Supplier management.

Macquarie Park, New South Wales, Australia

Sterile Biotechnology manufacturing.Plasma fractionation.Deviations Investigations, Change Controls and CAPAs.EDMS implementation. Team & Project management. Process improvements.Auditing.

Macquarie Park, New South Wales, Australia

• Australia & New Zealand Licence maintenance.• Quality Agreement maintenance.• Wholesale management.• Complaints, deviations, CAPA. continuous improvement.• Product release for distribution. • Product launch.• QMS maintenance. • Project management.

Sydney, New South Wales, Australia

• Perform Quality Responsible Person role for the importation, storage and distribution of Merck Sharp & Dohme (ANZ) products in Australia and New Zealand.• Maintenance of all aspects of the QMS.• Wholesale License application and maintenance.• DPCP application and updates.• Quality Management of suppliers.• Review and approval of transport validation.• Co-ordination of product Recalls/Mock Recall.• Quality Agreement maintenance.• Continuous improvement initiatives.

Sydney, New South Wales, Australia

Continuation of Senior Quality Specialist role after Shire was acquired by Takeda. Perform authorised person role for the importation, storage and distribution of Medicinal products(Unscheduled, Scheduled, Controlled Drugs) in Australia and New Zealand.• Aligning internal procedures with both local and Shire’s global requirements.• Development of all aspects of the QMS - TrackWise, Complaints, Deviations, CAPA, SOP, Validation, Recall, Quality Incident Management, Root Cause Analysis, FMEA, Risk Assessments• Licence application and maintenance.• Supplier Management.• Support product launches in the APAC region.• Internal and external auditing.• Quality Management system introduction, development and application. • UAT SAP implementation and ongoing SAP SME.

Perform authorised person role for the importation, storage and distribution of Medicinal products(Unscheduled, Scheduled, Controlled Drugs) in Australia and New Zealand.• Aligning internal procedures with both local and Shire’s global requirements.• Development of all aspects of the QMS - SOP, TrackWise, CAPA, Complaints, Deviations, Recall, Quality Incident Management, Root Cause Analysis, FMEA, Risk Assessments• Licence application maintenance.• Supplier Management.• Support product launches in the APAC region.• Internal and external auditing.• Quality Management system introduction, development and application. • UAT SAP implementation and ongoing SAP SME.

Sydney, New South Wales, Australia

Integral member of team involved in build of aseptic manufacturing site taken to fully operational grade B clean room for sterile medicines within 6 months including QMS development and validation.• Aligning internal procedures with both local and international regulatory and customer requirements.• Development of all aspects of the Quality Management System.• Quality Risk Assessment and CAPA system maintenance.• Approval of, Quality Risk Assessments, Change Controls and Batch Records.• Review and approval of all Qualification and Validation documentation.• Auditing of quality systems and evaluation of suppliers.

Sydney, New South Wales, Australia

• Management & development of QA & QC teams comprising 10 staff members• All aspects of maintaining manufacturing licence.• Aligning internal procedures with both local and international regulatory and customer requirements.• Maintenance of all aspects of the QMS.• Customer complaint receipt, investigation and closure.• Responsible for Quality Risk Management and CAPA systems.• Troubleshoot and resolve manufacturing Deviations, OOS and Complaints.• Approval / completion of Quality Risk Assessments, Change Control, Batch Record and PQR.• Review and approval of all Qualification and Validation documentation (VP, URS, IQ, OQ, PQ)• Qualification of warehouse and cool rooms including temperature mapping studies and reports.• Release for supply and release of products to the customer.• Supported and consulted on all major projects initiated on site.• Principal Customer and Regulatory audit host.• Principal Supplier auditor.

Arklow, Wicklow, Ireland

• Schedule QC Analysts, QA Document Controller and QA Engineers work load (15 people).• Appraisal/Performance review of department personnel• All aspects of Regulatory Affairs (Letters of access, deficiency letters, Drug Master Files).• Out-Of-Specification and Laboratory Deviations.• Approval of Process Deviations, Failure Investigations, and Customer Complaint Investigations.• Maintain validated status for equipment, control systems, processes and analytical methods.• Final approval of all raw materials, intermediates and finished products.• Technical approval of SOPs, validation documents (IQ, OQ, PQ) and technical reports.• Facilitating continuous improvement resulting in improvements in returns, defects and reworks.• Issue and execution of prospective and retrospective Process Validation protocols.• Preparation of Drug Master Files, Letters of Access and Deficiency Letter corrective actions.• Liaising with customers on regulatory issues.• Drafting of SOP's, Monographs and Master Batch Records.• Approval of validation documents including Process, Cleaning, Equipment and Control Systems.• Conducting internal cGMP audits and carrying out supplier and corporate audits throughout Europe.• Hosting customer and Regulatory audits (hosted 1 FDA audit and 2 IMB audits).

Arklow, Wicklow, Ireland

• Review and approval of batch related documentation and final product release.• Investigation reporting including Process Deviations, Out of Specifications, Material Failures and Customer Complaints.• Preparation of Annual Product Reviews• Operation and maintenance of the documentation system including Change Control.• Preparation of Drug Master Files, Letters of Access and Deficiency Letter corrective actions.• Liaising with customers on regulatory issues.• Responding to Customer/Regulatory audits and implementing corrective actions.• Conducting internal cGMP audits and tracking completion of corrective actions.• Provide quality related training to others.• Site Validations activities including Process, Cleaning and Equipment validation.• Drafting of SOP’s, Monograph and Master Batch Records.

Master Of Biomedical Science, Biological And Biomedical Sciences, Honours

Bachelor Of Science - Bs, Chemisty, Biology

Msc, Biological And Biomedical Sciences