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Senior QA Logistics Specialist

Kyowa Kirin - Amsterdam
Overview Responsible for the following Territories: Licences established in the Netherlands with supply and distribution into the EMEA region as well as import and export activities.Youparticipate in the compliance with
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Logistics Centre Quality Specialist (QP)

Oxfordcorp - 23-08-2022 Naar vacature  

" Are you a QP person? Or do you have 5 years' experience in Quality Compliance within Logistics / Supply Chain (pharmaceutical industry)? Also fluent in English and ready to work at Zaventem after Covid? Then we have your dream job !!"

Job description

The Logistics Centre Quality Specialist is accountable for providing quality oversight management of the logistics service provider for Pfizer located in Belgium and for assuring that the products are stored in accordance to GDP, Belgian legislation and Pfizer Quality Standards.

This is a project operating with minimal supervision, interacting with multiple stakeholders within Pfizer.

Responsibilities

  • Participate in Logistics Service Provider Quality oversight
  • Drive the development, implementation and continuous improvement of Quality Systems to support GDP and Pfizer Quality Standards
  • Proactively support regulatory or Pfizer-internal inspections at Logistics Service Provider and ensure appropriate Pfizer review/approval responses to Regulatory Agencies/Internal Audit functions including tracking of CAPAs within QTS.
  • Provide Quality Leadership for significant deviation events or failure investigations with Logistics Service provider that may impact compliance status or require regulatory notifications
  • Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities
  • Provide Logistics Quality oversight metrics to SQRT and participate in relevant meetings
  • Lead quality risk management activities and manage mitigation plans within Logistics Service Provider when appropriate
  • Provide quality leadership for customer Intercompany Operations Logistics investigations and manage the relationship with Pfizer Quality organisation and Pfizer/External sites
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.

Profile

  • A minimum of a bachelor's degree in sciences or Engineering, RP qualified.
  • A minimum of 5 years previous experience is required within the pharmaceutical industry - preferably within the Quality and/or Compliance fields
  • Experience with external suppliers/contractors is preferred. Experience with Distribution is mandatory
  • Knowledge of pharmaceutical cGMPs and GDP and global governmental regulations
  • Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
  • Good interaction and clear communication skills with multiple stakeholders is required.
  • Fluent in English (spoken and written), ability to speak and read other European languages will be an added advantage
  • Diplomatic in communication with internal and external customers

Benefits

  • A balanced salary package based on your capabilities and experience.
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