Graduate Position: QA GMP Specialist
2 dagen geleden
source : Student.Be

About Us :

CONSULTYS is a global engineering and services consulting company exclusively dedicated to the bio industry. Since 2005 we handle major international laboratories’ technical projects.

Our 260 consultants are currently working on innovative projects in engineering, production, quality (QA, QC, validation), R&D and regulatory affairs across Belgium, Switzerland and France.

CONSULTYS is well-known for its values such as respect, transparency and performance. We truly believe in proximity management so that our consultants can develop technical competencies in a pleasant environment.

Our wide range of biotech competences allows us to provide our expertise in all stages of pharmaceutical industry lifecycle.

Job Description :

Consultys Benelux is looking for QA GMP specialist (F / M) to reinforce his Consulting team. As a consultant, you will be assigned to a client project being responsible for QA activities related to the QA Systems, QA documentation and / or QA oversight of internal and external partners.

You will establish adequate ways of working in alignment with cGMP, the client procedures and international / local regulations (ICH, GMP, FDA / EMA Guidelines)

Depending on the project, you may be responsible for :

  • Working closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP
  • Providing strong assistance in managing customer complaints and third-party claims
  • Authoring and revising standard operating procedures, policies and records
  • Controlling the process of out of scope, deviation, change control, annual product and maintain appropriate quality metrics
  • Working closely with others to determine root cause and potential preventative / corrective actions
  • Ensure timely closure of investigations
  • Monitoring QA process and manage communication and reporting according to a defined frequency
  • Supporting employee training to diffuse new regulations and policies
  • Providing oversight on software / equipments / processes validation according to QA standards
  • Collaborating on QA aspects with other departments (Production, QA, RA, PV, R&D, IT)
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