QA Specialist

Date:  9 May 2023
Department:  Medical/QA/Regulatory Affairs/Pharmacovigilance
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Permanent
Location: 

Amsterdam or Brussels, NL

Purpose

 

The Quality Specialist is responsible for quality assurance of Pharmaceutical Affairs. He/she plays an important role in maintaining and professionalizing the quality management system, documenting all required information and taking the necessary actions in response to findings.

Main Responsibilities

 

As a GDP Quality Specialist you are responsible for assuring quality within this organization. You play an important role in the maintenance and professionalization of the quality management system, documenting all required information and taking the necessary actions. For example, you take care of drafting and handling change control documents, deviations, investigatons and CAPAs. In addition, you are responsible for maintaining the internal and external audit plan. You prepare inspections, external audits and perform internal audits.

 

As a GDP Quality Specialist you act as a back-up for the Responsible Person within the Benelux organization and you contribute to the implementation of and compliance with GDP regulations. You are jointly responsible for developing procedures for, among other things, the local releases, complaint handling, returns and customer check. You also conclude agreements with customers, distributors and service providers. You maintain these relationships and approve any outsourced activities that may affect GDP.

In short: in this dynamic and versatile quality position you play an important role in the maintenance and professionalization of the quality management system for the Benelux organization.
 

Profile

 

  • Completed bachelor's degree, preferably in a biomedical or biopharmaceutical direction;
  • At least 2 years of experience in the field of QA within the pharmaceutical industry;
  • Knowledge of GDP;
  • Experience with project-based work;
  • Independent, proactive, analytical and communicative skills;
  • Excellent oral and written communication skills in both Dutch and English.

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