QA Compliance Reviewer

As a QA Compliance Reviewer, you play a key role in ensuring compliance with cGMP’s and SOP’s. You follow up the necessary documentation and communication towards the team.

Job

You act as the point of contact within the team and provide assistance to other departments on matters of compliance.
You are punctual in following up on possible issues and change-related documentation.
You rectify daily deficiencies within reviewed documentation, strictly following cGMPs and SOPs.
You ensure MES project compliance with procedures and regulations and instigate non-conformance investigations.
You convey up-to-date status reviews to the team, consistently updating tracking spreadsheets and reports.
You coordinate with project teams to refine and expedite the batch records cycle time.
You compile production information for OOS, Deviation, and CAPA logs.
You ensure the availability of production documents and perform quality review for executed batch records.

Profile

What we expect from you

You have a Master’s degree in Biomedical Sciences, Bioscience engineering, Biochemistry, Industrial Pharmacy, ...
A first experience in a pharmaceutical or biotech environment is a plus.
You have an eye for detail, strong analytical and problem-solving skills.
Accuracy in e.g. administration is one of your strong points.
Fluent in Dutch and English.

Benefits

What you can expect from us

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world.At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

Company profile

About The Member Company

We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as: