Quality Executive応募後で応募 求人ID R0031553 掲載日 06/15/2021 Location:London, United Kingdom
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Quality Executive in our UK Head Offices in Central London, Paddington.
As our successful Quality Executive, you will provide technical and administrative quality support for the local operating company (LOC), for GxP, Commercial and R&D areas, to ensure adherence with relevant internal and external policies and procedures.
You will support GDP activities and the local quality release of batches of medicinal product for the UK & Ireland markets under the company Wholesale Distribution Authorisations.
- Quality Assurance: You will support the change control, deviation, risk assessment and product complaints processes and assist with the performance of pre-qualification assessments and regular audits and evaluations of vendors as required by the business
- Quality Systems: You will be responsible for all aspects related to the local QMS, including the writing and management of SOPs, the electronic quality systems and learning management systems.
- Quality Compliance: Assist with planning and performance of self-assessments and preparing for and supporting internal and external audits. You will work with team members to compile periodic reports (monthly/annually) and escalate quality issues. Seek to protect patient safety and escalate non-compliances arising in the business as appropriate.
- Quality Improvement: Contribute to Quality Improvement Planning, Management Reviews, quality projects etc. Ensuring quality standards and deadlines are consistently met and documentation is completed accurately and to a high standard
Maintenance of the Takeda UK and Ireland Quality Management System (QMS):
- Ensuring that local quality release of batches of medicinal product for the UK & Ireland markets is performed in an accurate and timely manner and in compliance with regulatory requirements
- Ensure compliance with Global and Local Quality principles, standards, policies and SOPs
- Track operational Quality and Compliance
- Issuance of all documents used within the QMS, including maintenance and control of local SOPs, including alerting SOP owners of SOP review dates, tracking updates to the SOPs, performance of gap assessments between global and local procedures in a timely manner
- Author, review and approve SOPs as required
- In cooperation with other team members, prepare periodic Quality reports
- Review, process, track and close out Change Controls/Deviations/Risk Assessments, including liaising with relevant Heads of Department to perform root cause analysis, and to discuss and agree CAPAs
- Support and facilitate the roll-out of Global Electronic Document/Learning/Quality Management Systems as required by the business
- Ensure all personnel receive the necessary training via the e-learning systems and that training delivered follows Global standards:
- Ensure training matrix is in place for relevant staff with responsibilities defined within the QMS and documented appropriately
- Assist with the performance of Quality inductions for all new starters
- Assign relevant SOP training to all staff (including service providers) and ensure that training records are kept using the e-learning system
In conjunction with other Quality team members, assist with the audits/self-inspections programme, including:
- Support and monitor self-inspection activities and audits (including internal audits, external audits of supplier and external inspections of the local business systems and processes)
- Use audit expertise to support audits in GDP parts of the organisation
- Maintenance of a tracker of all audits and their respective CAPAs
- Assist with vendor/third party selection and management, including:
- Ensuring that due diligence has been performed prior to the contracting process being initiated.
- Assist with coordinating and performing pre-qualification audits of vendors (including, for example, PV, Market Research, Patient Support Programme and HomeCare Service Providers)
Quality contact point for local, international, and global teams on UK/Irish Quality matters:
- Work with local cross functional teams
- Attend and participate in local and global meetings/calls as required, and present on quality topics when requested
- Build good relationships with internal and external stakeholders, particularly within the local business, Global Quality and at the Regulatory Authorities
- Prepare for and contribute to Quality Council meetings
- Support with periodic requests (e.g. Quarterly PSMF reviews, Compliance Investigations)
Education, Skill and Experience
- BSc in a scientific discipline.
- Experience working in a quality department or with managing quality related documentation (such as standard operating procedures) in another related function, such as Pharmacovigilance, Compliance or Finance
- Experience of writing and updating SOPs with clarity, accuracy, and rigor
- Knowledge of GDP requirements
- Experience of working within electronic quality and document management systems
- Experience of working with Enterprise resource planning (ERP) systems
- Excellent organizational, planning and time management skills.
- Computer literate, including Adobe Acrobat and Microsoft Word/Excel.
- Excellent attention to detail.
- Can effectively prioritise and manage multiple competing tasks and demands
- Appreciates and advocates the importance of being compliant and maintaining compliance records
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
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