Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
QA Compliance Officer
Within the QA operations department we are looking for a QA specialist for production plant 1. In this position you are responsible for quality support for the introduction and project integration of multiproduct launch unit, a standardized mAbs process platform, in the existing APU plant 1 organization
Scope of work:
- Drafting and reviewing Quality documentation in the context of the project (Project notes, Quality plans, …)
- Follow up and review of general project documentation (risk assessments, validation plans, procedures, batch records, …)
- Sharing quality support and expertise related to clinical manufacturing vs commercial manufacturing
- Prepare and review project documentation (e.g. procedures, risk assessments) with a view to deviation prevention (DPP) and human error prevention (HEP)
- Be in compliance with SOPs, global standards, regulations and product registration (filing) related to clinical and commercial manufacturing
- Provide quality support for process validation activities
- Execution of GEMBA (e.g. follow-up of physical project works, shakedowns, Deviation prevention, …)
Who are you?
- Master in a scientific direction or equivalent through experience
- Knowledge and interpretation of cGMP in a regulated environment
- Knowledge and interpretation of 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
- Good knowledge of the English language
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.