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Qualified Person

Location
Berlin
Posted
1 May 2022

Do you want to work at an international Biotech company working with highly motivated and top performers in an innovative and collaborative environment?


We are looking for a Qualified Person for a renowned Contract Development and Manufacturing Organization which has many years of experience in the development and production of biopharmaceutical active ingredients and vaccines. Every day, more than 220 employees contribute with their creative and careful work to the establishment of new therapy developments in medicine and ground-breaking innovations worldwide.

With our research, we support the development of effective and safe medical agents so that diseases such as cancer can be better cured. To produce these active ingredients, we use state-of-the-art cell technologies, most of which we develop ourselves. We are also helping to cope with the COVID-19 pandemic.


Become part of the success story and apply now as a Qualified Person (m/f/d):


Your field of responsibility

Batch release of active ingredients and finished products as "investigational medicinal products"

Setup and guidance of a shop floor QA including batch record review and quality oversight

Evaluation, monitoring, and completion of non-conformity events and change control procedures from the operational areas

Preparation of the quality management processes for an Annex 1 GMP certification including the preparation of GAP assessments, the preparation / establishment of the Control Contamination Strategy

Implementation of GMP training courses


Your profile

Completed scientific studies and proof of expertise as a qualified person in accordance with AMG §15

Experience as a Qualified Person in Sterile Production under EU GMP Guidelines Chapter 4 Annex 1

Experience in biotechnology is an advantage

Very good knowledge of English and German


Benefits

Flexible and family-friendly working time model

Modern working environment

International environment

Working with creative minds

Offering Trainings and workshops

Discount on sport clubs


Contact Details:

For further details please contact Saba Pakdel here on LinkedIn or call me on +49 30 767 580 496 or email directly at saba@ to discuss in confidence.

Become part of the success story and apply now!

Apply for this job now

Details

  • Job Reference: 579008906-2
  • Date Posted: 1 May 2022
  • Recruiter: Meet
  • Location: Berlin
  • Salary: On Application