Quality Assurance Manager

Quality Wevelgem, Belgium


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

We are looking for an experienced QA manager to join our site based in Wevelgem. The ideal candidate will have a background in the pharmaceutical sector and display a strong drive to make a difference in a rapidly changing environment!

Your responsibility:

  • The release of medicines, medical devices, food supplements and cosmetics for the European market;
  • the follow-up of changes in relevant legislation and its correct implementation;
  • the execution of internal audits;
  • the supervision of external audits and inspections by competent authorities;
  • the approval of procedures, instructions, specifications, ...
  • representing QA in transfer and improvement projects;
  • drawing up and following up CAPA plans;
  • drawing up risk analyses;
  • Drafting Quality Product Reviews;
  • Monitoring and supervising qualification and validation of methods, infrastructure and processes;
  • The preparation of process validation reports;
  • Drawing up supplier evaluations and assessment of suppliers and/or manufacturers;
  • Drawing up training plans;
  • the training of GMP related subjects (initial training and maintenance);
  • Monitoring deviations and supervising root cause analyses;
  • Managing changes with GMP impact

 

Requirements

  • Master's degree in pharmacy
  • 7 years of experience as a quality manager within a GMP environment (preferably pharmaceutical sector).
  • Registration as an Authorized Person (QP) is a plus, not a must.
  • Strong people skills; to coach, develop and motivate our driven team (4 people).
  • Project Management skills, you will represent QA on company led projects.
  • You work in a very structured, planned, proactive and result-oriented way and can function perfectly both autonomously and as a team.
  • Solution orientated & hands-on mentaility
  • Familiarity with HACCP, ISO13485 and ICH.
  • MS Office applications (Word, Excel, PowerPoint).
  • Knowledge of SAP & Trackwise is a plus.
  • Fluent Dutch and English (both spoken and written); your knowledge of the French language is an additional advantage.