Manager QA Projects New Chemical Entities (f/m/d), 80-100%
Key information
- Publication date:23 October 2024
- Workload:80 – 100%
- Contract type:Permanent position
- Language:German (Intermediate), English (Intermediate)
- Place of work:Bubendorf
Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot. Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz. In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.
To drive our continuous organic growth, we are constantly looking for highly qualified specialists. To strengthen our team in Quality Assurance III NCE, we are looking for a dedicated Manager QA Projects (f/m/d), 80-100%.
Your tasks:
- Representation of QA in NCE projects at the Bubendorf site.
- Assessing and deciding on QA-relevant issues in the individual projects.
- Coordination of project-related tasks within the QA departments and contact person for other departments and areas (e.g., production, quality control, project management) in questions of cGMP compliance and troubleshooting.
- Define a control strategy and overall project lifecycle strategy for late phase projects including process validation to support the commercial manufacturing phase.
- Review and approval of GMP documents, changes, deviation reports and CAPA actions.
- Contact point for our clients for QA-related questions and representation of QA in meetings between Bachem and the respective clients.
Your profile:
- Master or Ph.D. in chemistry, biology, pharmacy, or comparable technical degree.
- 2 years of professional experience in project management in the chemical / pharmaceutical industry.
- High level of understanding of broad quality assurance aspects, sound cGMP knowledge (EU-GMP, FDA) and experience in accompanying process validations incl. risk management.
- Particularly good verbal and written communication skills in German and English.
- High level of comprehension and a structured personality capable of making decisions.
- Resilient, service-oriented, communicative, and flexible personality with the ability to present complex events and contexts in an understandable way and to communicate internally and externally.
Our offer:
- A dynamic and fast-growing working environment with internal development opportunities.
- Flexible working hours with the possibility of working from home and the option to take additional vacation days with a reduced workload.
- Employee development through various internal and external training opportunities.
- 60 % of pension fund contributions paid by Bachem AG as well as the option of extra-mandatory pension provision with our optional savings plan.
- Access to the Swibeco benefits platform with discounts from external partners.
Would you like to drive innovation together with us?
Have we piqued your interest? Then we look forward to receiving your complete application documents via our application portal.
Find out more about the Bachem Group and be inspired by our inspiring working environment at our site in Bubendorf!
Contact
Bachem AG
