Data Assurance and Risk Management Lead

4 weeks ago


Windsor Berkshire, United Kingdom OTSUKA PHARMACEUTICAL EUROPE LTD. Full time

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.



  • Windsor, Berkshire, United Kingdom OTSUKA PHARMACEUTICAL EUROPE LTD. Full time

    Job 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...

  • Technology Quality

    3 weeks ago


    Windsor, Berkshire, United Kingdom ABC Technologies Full time

    About ABC Technologies ABC Technologies is a leading global manufacturer and supplier of custom, highly engineered, technical plastics, and light-weight innovations to the North American light vehicle industry. An Engineering Outsourced Leader in an injection molding plant is responsible for managing and coordinating engineering projects and tasks that are...


  • Windsor, United Kingdom Centrica Full time

    **Senior Assurance Assessor - Ethics & Compliance** Centrica are evolving to become a truly purpose-led organisation, helping millions of customers to live more sustainably, simply and affordably. We believe that we have a huge role to play in helping the nation to cut carbon emissions and prepare for a net zero future, and it’s a role we are immensely...


  • Windsor, United Kingdom Parkside Recruitment Full time

    Reference: - 89777- Sector: - Administration, Medical Secretary- Salary: - £40,000 to £45,000 Per Annum- Benefits: - bonus- Town/City: - Windsor- Contract Type: - Permanent- Date Posted: - 13/06/2023 15:34:00An amazing opportunity for a Quality Assurance Specialist to work for a dynamic and vibrant organisation within the pharmaceutical industry, my client...


  • Slough, Berkshire, United Kingdom Service Care Solutions Full time

    Quality Assurance Manager Start date - ASAP Contract length - Initially 3 months The Quality Assurance Manager will play a critical role in ensuring that Slough Borough Council delivers effective quality assurance and evaluation of care and support services. They will manage a small team of Principal QA officers and four staff within the Market...

  • Credit Risk Manager

    2 weeks ago


    Windsor, United Kingdom Centrica Full time

    We are Centrica! We’re so much more than an energy company. We’re a family of brands revolutionising a cleaner, greener future. Working here is #MoreThanACareer - we’re powered by purpose. Together we can make an impact that will truly change tomorrow. Whether you’re developing cutting-edge green tech, helping customers on the front line or...


  • Reading, Berkshire, United Kingdom AWE PLC Full time

    We need an AWE some Enterprise Risk Manager to join our growing 2nd Line team and play their part in ensuring AWE delivers it's vital mission. Can you be a critical yet supportive friend to our corporate functions and help them provide assurance to the board that they are managing their key risks and controls? If you are an experienced Enterprise Risk...


  • Reading, Berkshire, United Kingdom BDO Full time

    Ideas | People | Trust We're BDO. An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today's changing world. We work with the companies that are Britain's economic engine - ambitious, entrepreneurially-spirited and high-growth businesses that fuel the economy - and...


  • Reading, Berkshire, United Kingdom BDO UK Full time

    Ideas | People | Trust We’re BDO. An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today’s changing world. We work with the companies that are Britain’s economic engine – ambitious, entrepreneurially-spirited, and high‑growth businesses that fuel the economy – and...


  • Reading, Berkshire, United Kingdom BDO Full time

    Ideas | People | Trust We're BDO. An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today's changing world. We work with the companies that are Britain's economic engine - ambitious, entrepreneurially-spirited and high-growth businesses that fuel the economy - and...


  • Windsor, Berkshire, United Kingdom Alchemy Global Talent Solutions Full time

    Our client, a leading immigration consultancy firm based in Windsor, is looking for an Immigration Assistant to join their team. who specialise in providing comprehensive immigration services to individuals and businesses; by assisting with various administrative tasks and client interactions to ensure the efficient operation of their immigration consultancy...


  • Windsor, Berkshire, United Kingdom Alchemy Global Talent Solutions Full time

    Our client, a leading immigration consultancy firm based in Windsor, is looking for an Immigration Assistant to join their team. who specialise in providing comprehensive immigration services to individuals and businesses; by assisting with various administrative tasks and client interactions to ensure the efficient operation of their immigration consultancy...


  • Reading, Berkshire, United Kingdom Ciphr Full time

    Ciphr has a new opportunity for a Head of Quality Assurance. Flexibility is key so this role can be based anywhere within the UK if you are happy to attend ad hoc meetings. We also have an office in Reading, Berkshire that all Ciphr employees are welcome to utilise. The role is remote within the UK but require occasional travel for meetings. See below...


  • Slough, Berkshire, United Kingdom Randstad Sourceright Full time

    Quality & Food Safety Coordinator Location: Slough/Hybrid Contract length: Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a Quality & Food Safety Coordinator on behalf of a well known business that specialises in Engineering, Rail, Healthcare and Energy The External Manufacturing Quality & Food...


  • Windsor, Berkshire, United Kingdom Tessonics Inc. Full time

    Job Summary: We are seeking a detail-oriented and experienced Quality Assurance Technician to join our team. As a Quality Assurance Technician, you will be responsible for ensuring that our products meet the highest quality standards through thorough inspection and analysis. Your attention to detail and expertise in quality control will play a crucial role...

  • Risk Management Lead

    4 weeks ago


    Wokingham, Berkshire, United Kingdom Compass Associates Full time

    Regional Clinical Lead – North West – Complex Care ~ Job Title: Regional Clinical Lead – North West – Complex Care Hours : Full-Time (with some evenings and on-call) North West (Hybrid Remote) Benefits/Bonus: On completion of successful probation, entry to the company bonus scheme Pension Scheme Continued professional development...


  • Reading, Berkshire, United Kingdom Ciphr Full time

    Ciphr has a new opportunity for a Head of Quality Assurance. Flexibility is key so this role can be based anywhere within the UK if you are happy to attend ad hoc meetings. We also have an office in Reading, Berkshire that all Ciphr employees are welcome to utilise. The role is remote within the UK but require occasional travel for meetings. See below the...


  • Windsor, Berkshire, United Kingdom Meet Full time

    Job Title: Quality Manager, Global Quality Management Are you a Pharmacovigilance professional with a keen eye for quality management? Do you possess experience in audits, inspections, and CAPA management, and aspire to transition into a broader Quality role? We have an exciting opportunity for you to join our Global Quality Management team as a...


  • Windsor, Berkshire, United Kingdom All-Risks Insurance Brokers Limited Full time

    Job Description All-Risks Insurance Brokers Limited is a full-service insurance brokerage offering a broad array of property, casualty, life, health, and investment products and services to the residents of Ontario. We offer our customers a choice of high-quality insurance products from a number of reputable and financially secure insurance companies in a...


  • Reading, Berkshire, United Kingdom BDO Full time

    An accountancy and business advisory firm, providing the advice and solutions entrepreneurial organisations need to navigate today's changing world. We work with the companies that are Britain's economic engine - ambitious, entrepreneurially-spirited and high-growth businesses that fuel the economy - and directly advise the owners and management teams...