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  • Location

    Netherlands

  • Job title:

    External Site Quality Lead (ESQL) and Product Quality Manager (PQM)

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    49101

  • Start Date:

    2022-09-12

Location: Amsterdam
Duration: 6 months contract 
Working: Full time (40 hours) 

Company
Our client is a global healthcare company  with a mission to provide medicines and solutions that impact healthier lives.

About the role
In the role you will be accountable for ensuring that all of Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.

Responsibilities 
-Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc)
-Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company
-Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements
-Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews

Preferred Requirements
-Relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
-Previous experience participating in regulatory inspections
-Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships