Third Party QA Senior Specialist
- Masters in Biomedical & Biological Sciences, Chemistry, Biochemistry, or Pharmacy
- Regulatory Affairs experience
- Fluency in English
- 7 years of experience in GMP, Quality, Operations, or Manufacturing
- Experience with third party management.
- Proficient in Italian, French, or German.
Ensure QA Oversight of third parties involved in the Clinical Manufacturing and Supplies environment
- Be the SPOC (Single Person of Contact) in the US RDC for all GMP related topics
- Be the quality contact for the group of third parties he/she is responsible for and for the internal stakeholders involved in activities contracted to these third parties
- Monitor and manage the quality performance of these third parties, and ensure they operate in compliance with GSK standards and requirements
- Organize and manage the quality governance meetings for these third parties
- Write, coordinate and ensure the follow up of the quality contracts approval and update, when necessary
- Ensure the collaboration with third parties is continuously in compliance with quality agreements and/or other relevant contracts
- Ensure complaints, deviations, change control, CAPAS, validations related to third parties are handled in a timely manner and in compliance with cGMP's and Quality Contracts
- Ensure accountability for CAPA closure for regulatory (L4) and corporate audit (L3).
- Ensure accountability for Third Parties data base (Set up, update, …)
- Ensure Quality Systems at CMO site are regularly updated and in line with GSK QMS, through oversight and efficient analysis tool
- Be part of the third parties selection and approval process, as appropriate. Manage the approval status of these third parties
- Ensure Issues and Risks are adequately identified, analysed, assessed, mitigated and escalated
- Be involved in the third parties release certification and re-assessment process
- Review and approve all the required documentation for the batch release process, and ensure its correct archiving
- Ensure all the documentation related to these third parties is correctly reviewed, managed and archived according to GSK requirements
- Be involved in third parties audit organization, preparation and execution, as appropriate
- Be part of the transfer team for product/process transferred from GSK to a third party and from a third party to GSK
- Provide a helpful support to CMO in case of issues, in a proactive manner
- Manage its own performance and contribute to the performance of the QA TPO team in line with the lean culture principles
- Drive continuous improvement through KPI and action plans.
- Ensure SOP's and systems related to TPO management are up-to-date and compliant with the current regulatory requirements and regulations
- Represent QA TPO team at governance meetings, in delegation of the Head of TPO, when needed
You may apply for this position online by selecting the Apply now button.
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