GMP Compliance
Brabant-Wallon – contracting
Our partner is looking for a GMP Compliance to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
- Ensuring potentially the release of the commercial batches in compliance with the Good Manufacturing Practices and regulatory requirements
- Maintaining the compliance level with GMP regulations/requirements within the EM
- Being the Quality contact point for the selected contractor / supplier you are support for
- Ensuring that Quality systems are in place/in use, routinely monitored and assessed
- Ensuring accountability for all quality activities linked to the contractor / supplier management (deviations, CAPA closure, risks management, complaints, product quality review, changes handling)
- Maintaining a good relationship with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings
- Representing Quality EM within various governance meetings and timely escalate issues to Manager when required through established process
- Potentially managing Questions & Answers packages and commitments linked to Health authorities requests in due time
Who are you?
- You hold a university Scientific background (Pharmacist, PhD in Life Sciences, Bio Engineer, etc.)
- You have experience within the pharmaceutical industry on the field (QA, Manufacturing)
- You have knowledge in sterility assurance/Secondary operations and a good understanding or experience in product release
- You are fluent in English and in French
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Aurélie Montes Suarez: [email protected] or +32472/44.83.18
