Product Quality Senior Expert
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Act as the Quality Representative for Regulatory Compliance for Plasma derivative products as well as for Biologics products dispositioned at the Lessines facility.
- Ensure that the internal quality systems are compliant with the quality specifications, license requirements and applicable
- Act as a product quality expert for products handled by the site.
- Support the preparation of the necessary documentation for product license by providing the required information to applicable RA (Regulatory Affairs) functions, in case of geographical expansion, tender or license renewal:
- Prepare support documentation for changes and regulatory questions.
- Respond timely to Regulatory Agencies questions or requests in the context of new licenses or application renewals.
- Support the PQL (Product Quality Lead) in the preparation and review of regulatory submissions and associated request for information.
- Ensure Timely issuance of the facility Product Quality Review (PQR) Reports (coordinate data collection, assess conclusion of SME and evaluate the necessity of further action if any as part of the final PQR summary report). Act as a key contact for external partner to get report approved on-time.
- Review and ensure maintenance of Quality Agreements.
- Perform Inter-Facility Changes Assessments (IFC).
- Support on-site Regulatory Inspections.
- Act as a Site contact point for global PQL (Product Quality Lead) in Quality Team Matrix & Regulatory functions.
- Various interactions with internal departments and functions (Release, Qualified Person, Receiving & Inspection, Supply Chain, Quality Control, Artwork Management, Validation).
- University degree or equivalent: Engineering, Biochemistry, or equivalent by several years of experience
- Fluent in French and English (written and spoken)
- Excellent communication skills: able to communicate with different internal departments (RA, Manufacturing, QC…) and external parties.
- Technical writing skills is an asset
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0039895