Arcadis Diepenbeek, Flemish Region, Belgium
Quality Assurance Engineer
We are looking for a QA Engineer who has a startup vibe. Be part of a joint mission and set the new standard in biopharmaceutical manufacturing technology.
Job content
As a QA Engineer, you will combine project QA tasks, routine QA tasks, as well as maintenance of the Quality Management System (QMS) within the company.
Responsibilities:
Project QA
* Support implementation of new products at our GMP site
* Discuss and review tech transfer data packages and implementation documents
* Write and review project specific validation protocols & reports
Routine QA
* Issue master batch records and conduct batch record review
* Support and review of Environmental monitoring activities
* Release incoming materials and write material specifications
* Assist in supplier qualification and requalification
* Ensure QA oversight on Good Documentation Practices and Good Manufacturing Practices
Maintain the (electronic) Quality Management System
* Review & follow-up of events, planned deviations, supplier complaints, OOS, CAPA, and change requests
* Write and review SOPs, work instructions and forms
* Archive records and files
* Prepare management review documentation
* You work closely together with the head of quality
You engage in a broad range of activities in order to grow into a strong and reliable partner for future clients.
Education:
Master Degree in Biochemistry, Chemistry, Pharmaceutical Lab Technology or equivalent through relevant experience. Ideally, you already have +/- 3 to 5 years of working experience in a GMP environment.
Competences:
Technical skills:
* Skilled in GMP and Good Documentation Practices
* Quality minded
* High degree of accuracy, well organized and result oriented team player
* Fast assembly of new information
* Swift learning on the job
* Strong and honest communicator
* Flexible both in content as in time (occasional working during the weekend, early morning, evening or night)
* Enjoying the start-up flow of our organization
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Pharmaceutical Manufacturing and Biotechnology Research
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