Data Assurance and Risk Management Lead
4 weeks ago
Oversee supplier related changes and implementation of required actions to address changes. •Track supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.
•Communicate to management quality and regulatory issues on a timely basis.
•Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits.
•Drive compliance excellence by assurance of compliance through robust Global Quality Management Systems, risk-based Global Audits, cross GxPs Inspection Readiness and strong partnership with the business functions to enable Otsuka product success.
•Contribute to the development of and maintenance of the quality system
•Prepare and maintain GMP documentation such as standard operating procedures and Quality Technical Agreements
•Act as approver of certain Quality Technical Agreements
•Liaise with suppliers for the management of returned/defective Product
•Contribute to Global Quality goals, projects and initiatives
•Perform activities on behalf of the Responsible Person for Wholesale named on OPEL’s Wholesale Distribution Authorisation and deputise for the Responsible Person/Senior Director, Global Product Quality as appropriate
•Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions
•Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.
•Provide support to other functions within the OPEL Global Product Quality team, such as:
•Supporting the Quality Control Laboratory
•Management, monitoring, review and approval of Change Controls, Deviations, CAPAs and PQCs
•Conducting training sessions on Quality processes
•Providing support to regulatory inspections
•Bachelor Degree level plus, further qualification in auditing desirable
•Several years’ experience working in a Pharma Quality Role.
•Excellent written and spoken English.
•Industry experience of manufacturing, automated packaging and distribution sites (GMP and GDP)
Well organised, with strong planning skills and an ability to grasp complex and multifactorial data quickly.
•Very good written and spoken English
•Excellent time Management & organisational skills
•Experience in management of GMP/GDP Quality Management Systems
•Ability to negotiate with third parties on Quality processes
•Based at the OPEL office, with significant travel, mainly in Europe, but also in Asia and North America.
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Supplier Assurance Management Lead
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Windsor, Berkshire, United Kingdom OTSUKA PHARMACEUTICAL EUROPE LTD. Full timeJob Description Oversee supplier related changes and implementation of required actions to address changes. •Track supplier quality on a monthly/quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions. •Communicate to management quality and regulatory issues on a timely basis. •Maintain an Approved...
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Technology Quality
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Technology Risk Assurance Assistant Manager
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Technology Risk Assurance Assistant Manager
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Telephone Data Assistant
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Quality Assurance Manager
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Quality Assurance Technician
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Quality Assurance Manager
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Senior Manager, Data Management
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Personal Lines Underwriter
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Technology Risk Manager
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