Sr QA Officer / QP trainee
Leiden
In this role you promote the awareness of quality, regulatory and customer requirements throughout the company. You will have the possibility to follow the trainings program to be certified as a Qualified Person. You will act as deputy QA Manager.
Locatie
Leiden
Functie omschrijving
In this role you promote the awareness of quality, regulatory and customer requirements throughout the company. You will have the possibility to follow the trainings program to be certified as a Qualified Person. You will act as deputy QA Manager.
You will be responsible for:
- Maintain a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products based on applicable regulations and guidelines
- Investigate customer complaints and act as point of contact towards customers for Quality related matters
- Review and approve investigations related to Out-of-Specification resultsa as well as batch records
- Host and support customer audits and regulatory inspections
- Support and review the qualification of production equipment, test equipment and cleanroom
- facility
- You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products)
Uitdaging
Our client offers:
- A responsible and challenging position within the team
- Plenty of room for your own ideas and input
- Professional training and opportunities for education and development
- Flexible working hours
- Good primary and secondary employment conditions
Profiel kandidaat
Qualifications:
- You hold a master’s degree in science in f.e. pharmaceutical sciences, Biomedical sciences, chemistry, or related educations
- You have knowledge of GMP quality system and regulatory requirements
- Preferred, you have knowledge of biological process development and manufacturing
- You are fluent in Dutch and English, written and spoken
- You have a high level of integrity
- You can easily prioritize your work
- You have strong decision making and problem-solving skills
- You are a fast learner
- You are a team player, able to work with all levels in the organization
- You have a Positive mind set
Bedrijfsprofiel
Our client is a GMP Quality Control laboratory, where analytical chemical testing of raw materials, drug substances and drug products is performed. A large part of this work involves routine testing. However, for new products, formulations or monographs clients require development or validation of analytical methods.
