Senior Quality Assurance Manager for New Chemical Entities
vor 4 Wochen
Bachem AG is a leading technology company focused on peptide chemistry, offering a comprehensive range of services for the pharmaceutical and biotechnology industries. We are seeking a highly qualified Senior Quality Assurance Manager to join our team in Bubendorf, Switzerland.
Your key responsibilities will include:
- Representing QA in NCE projects at the Bubendorf site
- Assessing and deciding on QA-relevant issues in individual projects
- Coordinating project-related tasks within the QA departments and serving as a contact person for other departments and areas in questions of cGMP compliance and troubleshooting
- Defining a control strategy and overall project lifecycle strategy for late phase projects, including process validation to support commercial manufacturing
- Reviewing and approving GMP documents, changes, deviation reports, and CAPA actions
- Serving as a contact point for clients for QA-related questions and representing QA in meetings between Bachem and clients
Requirements:
- Master or Ph.D. in chemistry, biology, pharmacy, or a 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, including risk management
- Excellent 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
We 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
Are you interested in driving innovation with us?
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