Third Party QA Senior Specialist

Basic qualifications:

  • Masters degree in biomedical or biological sciences, chemistry or biochemistry, pharmacist
  • Strong experience in regulatory environment
  • Fluent English level required
  • Strong internal as well as external networking skills to interact with R&D and other departments (eg: Finance, Legal)
  • Strong communication and organizational skills
  • Has a "can do" attitude, helping the organisation to deliver stretch goals
  • Demonstrates integrity, strives for excellence in her/his work
  • Availability to travel

Preferred qualifications:

  • Second language desirable (French/German)

Details:

Job Purpose

Ensure QA Oversight of third parties involved in the Clinical Manufacturing and Supplies environment.

Key Responsibilities

  • Be the SPOC (Single Person of Contact) for all gmp related topic in IT RDC.
  • 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.
  • Travel up to 30% mainly in Western Europe

Contact information:

You may apply for this position online by selecting the Apply now button.

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