Third Party QA Senior Specialist
Location:
Rockville , Maryland
Posted:
October 17, 2017
Reference:
WD133883
Basic qualifications:
-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

Preferred qualifications:
-Experience with third party management.
-Proficient in Italian, French, or German.

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

KEY REPONSBILITIES

-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

Contact information:

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