Manager QA Projects for New Chemical Entities

Vor 2 Tagen

Bubendorf, Schweiz Bachem Holding AG Vollzeit

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 ManagerQA Projects (f/m/d), 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 otherdepartments and areas (e.g., production, quality control, project management) in questions ofcGMP compliance and troubleshooting.
- Define a control strategy and overall project lifecycle strategy from early GMP developmentthrough process validation in the later phases 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 meetingsbetween 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 / pharmaceuticalindustry.
- 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 presentcomplex events and contexts in an understandable way and to communicate internally andexternally.

**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 takeadditional 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?

Find out more about the Bachem Group and be inspired by our inspiring working environment atour site in Bubendorf

**_Please note: unsolicited resumes from recruitment agencies will not be considered._

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