Jobs

QA Compliance Officer

Discipline
Engineering
Sector
Life Science
Location
Belgium
Vacancy ID
54173

Responsibilities

  • As a QA Compliance Officer you are responsible for quality support for the introduction and project integration of multiproduct launch unit and a standardized process platform. 
  • You have to draft and review quality documentation in the context of the project (project notes, quality plans, ...). 
  • You follow up and review of general project documentation (risk assessments, validation plans, procedures, batch records, ...). 
  • You share quality support and expertise related to clinical manufacturing vs commercial manufacturing. 
  • You prepare and review project documentation (e.g. procedures, risk assessments) with a view to deviation prevention (DPP) and human error prevention (HEP). 
  • You are in compliance with SOPs, global standards, regulations and product registration (filing) related to clinical and commercial manufacturing. 
  • You provide quality support for process validation activities. 
  • You are responsible for execution of follow-up of physical project works, shakedowns, deviation prevention, ...

Requirements

  • Master in a scientific direction or equivalent through experience.
  • Knowledge and interpretation of cGMP in a regulated environment, clinical manufacturing and regulations is an advantage.
  • Knowledge and experience with Quality Processes and Quality Assurance.
  • Superb accuracy and attention to detail.
  • Independence and a strong sense of responsibility.
  • An enthusiastic team player and strong in communication.
  • Good writing skills, and fluent in English. 

Let us handle the details

We at STAR are happy to take care of the details

01 // Education and development

Standing still in this fast-changing market is not an option. That's why you can combine this position at STAR with courses to further your specialist knowledge and skills. It's the best of all worlds: work, learn and be part of a challenging project all at the same time. Whether you need a springboard to launch your career or simply want to update your expertise, the training programmes offered by our STAR Academy ensure that your qualifications are always in line with your ambitions.

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