- The Quality Assurance Department (QA Research) is looking for a quality assurance professional (QA Specialist GMP) to support our team.
- The successful candidate should have a scientific background and demonstrate a high level of understanding of the application of quality assurance and compliance monitoring in regulated as well as non-regulated areas.
- The QA Specialist will be responsible for:
- Monitor compliance of the Quality Control department at BN-M (GMP), e.g. perform audits, training of staff as well as review and approval of documentation such as validations, qualifications, SOPs, change requests and deviations.
- Perform audits of internal processes as required by GMP (e.g. facility, process, raw data and documentation)
- Ensure BN-M compliance with relevant guidelines and regulations as well as company procedures also in view of audits and inspections.
- Support compliance activities (e.g. hosting of authority inspections and client audits).
- Maintenance of adequate quality procedures and guidance for non GxP regulated areas within R&D (BN Internal Basic Quality Standard).
- Training of staff on quality related issues
- Considerable experience of working within QA in a GMP regulated environment (including release testing); proficiency in other compliance disciplines desirable (e.g. GLP)
- Sound knowledge of EU and US regulations and guidelines (such as ICH, FDA CFR, AMG, AMWHV)
- Experience in and knowledge of drug development and manufacturing, GMP regulations and regulatory compliance.
- BSc / MSc or equivalent in a life science, experience with development of vaccines and biologics preferable
- Previous audit experience (supplier, laboratories, vendors) desirable
- Strong quality orientation including the ability to focus on details and adherence to standards
- Strong team player, self motivated
- Exemplary communication skills including an excellent command of English both written and spoken
- Willingness to travel as required
- An exciting and challenging position within a motivated and experienced international team.
- Contribute to and gain experience from working in a forward looking, international biopharmaceutical company