QA Specialist as Qualified Person (f/m/d) 100%. Hørsholm, DK
We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.
Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organization (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.
Are you looking for a challenging position in a foreign country such as Denmark? Are you willing to relocate? For our site in Hørsholm (DK) we are seeking an experienced and dedicated
QA Specialist as Qualified Person (f/m/d) 100%
The QA Specialist (Qualified Person) is a member of the Quality Assurance Team and plays an essential role in the implementation of Quality capabilities to support our clinical manufacturing site and to be responsible for the drugs substance release on site. The applicant ensures the guidance and hands-on Quality oversight for the GMP operation department and the development department’s according to the procedures and GMPs requirements. The applicant will report to the Head of Quality Assurance.
- Academic or university degree in pharmacy, microbiology, biotechnology, life science
- At least 5 years relevant experience in a regulated pharmaceutical environment
- Experiences in Quality Assurance or Quality Systems is an asset
- An accreditation of a Qualified Person from the Danish Health Authorities is an advantage
- Knowledge of biopharmaceutical clinical trial manufacturing and the requirements for the different clinical phases
- Strong background in GMP is an asset
- Structured, focused and well-organized working attitude
- Being agile, highly motivated, and dynamic drive is needed in this fast-paced environment
- Motivated to move topics forward and bring it to an end and deliver the right quality
- Good skills in communication and connection between interfaces, within organizations and sites
- Very good communication skills in English (verbal and written)
ROLE AND RESPONSIBILITIES
- Support the development of the company’s overall quality strategy
- Be Qualified Person on manufacturing site Hørsholm and therefore obtain the responsibility for the production process and the release procedure of the manufactured Drugs Substance
- Act as SME for Quality/GMP compliance at the site
- Establish, implement, maintain and monitor the processes for e.g. Document Management, Change Control, Deviation and CAPA Management.
- Conduct internal audits or supplier audits
- Being responsible for the Quality Oversight of the GMP facility in Hørsholm
- Review and release process intermediates
- Review and approve GMP documentation
- Ensures an effective information exchange/ flow to other departments or interfaces
- Advise and guide personnel in GMP topics or issues
- Perform GMP trainings on site
- Asist in Health Authority Inspection as Quality SME or in the organization of the inspection
You will be based in Hørsholm (near Copenhagen), Denmark and will report to the Head of Quality Assurance. Are you interested to work for an innovative, dynamic, and future oriented start-up company? If you are looking for a new challenging role, where you can create things and leave your footprint, send your full application to Ms. Sandra Gamboni, Head of Human Resources; firstname.lastname@example.org.