Qualified Person Vaccine

vor 1 Woche


Singen Hohentwiel, Deutschland Dembele Consulting GmbH Vollzeit

**Qualified Person Vaccine**(w/m/d)**

In our new and innovative QDengue project in Singen, Germany, you will take on a responsible role as a Qualified Person Vaccine (f/m/d). In this central position, you will be the contact person for Official Medicines Control Laboratories such as AGES and PEI and ensure the high quality of our vaccine Qdenga.

**What you will contribute**:

- Ensuring certification of the dengue vaccine according to cGMP, local and global guidelines and registration documents
- Processing, evaluation and assessment of deviations and complaints
- tracking of CAPA measures
- Monitoring and determining country-specific requirements in the disposition process
- Conducting Batch Record Reviews
- acceptance of batch certification
- Support with government inspections and internal audits

In this position you report to the Team Lead QPs and Batch Disposition.

**What you bring to Takeda**:

- Expertise in accordance with Section 15 (3) AMG as a QP for human vaccines; recognition by the German state authority or the prerequisite for obtaining recognition
- Many years of professional experience in the GMP environment of the pharmaceutical industry
- Very good knowledge of regulatory and quality management competencies
- experience with manufacturing processes
- Analytical thinking and quick understanding of complex issues
- Excellent cooperation and communication skills; ability to work in a team and independently
- Very good written and spoken German and English skills

**What we offer you**:

- Attractive remuneration
- Open-minded and modern working environment
- hybrid work model
- 30 vacation days
- company pension scheme
- continuing education and training
- travel allowance
- Generous moving package including brokerage fees
- subsidized canteen
- subsidized health and sports programs
- occupational disability insurance
- long-term account with various uses
- employee discounts
- share program
- group accident insurance
- performance-related bonus
- trust-based working hours
- employee referral program
- salary conversion options for retirement provision
- Global Wellbeing Program
- Interactive online courses for children of employees
- employee recognition program