As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Job role based at our site at Hegenheimerstrasse in Weil am Rhein, Germany Discover Impactful Work: The focus of this job is on the release/certification of clinical investigational medicinal products. In addition to an in-house induction, you will be involved in specific customer projects. These projects will be carried out both independently and together with our customers. Accompanying and conducting audits is another part of your job. Our common goal is to train and develop you in the area of quality assurance. A day in the Life: - Approval decisions for investigational medicinal products - Support of customer projects - Conducting audits (international) - Direct contact with authorities - Preparation of QP Declarations - Approval of SOPs. - Processing of complaints - Approval of the assignment of contract laboratories - Advising customers on QA issues - Responsibility for the decision on the use of batches of medicinal products for clinical testing in accordance with the AMG and EU Annex 13 and 16 - Review and approval of statements on deviations - Root cause analysis in case of deviations. - Review of manufacturing documents and validation documents Keys to Success: Education - Degree in Pharmacy with 2 years experience in pharmaceutical quality control - Licence as pharmacist and ideally expertise according to § 15(1), § 15(3a) sentence 1.-3. and §15(3) AMG - Qualified person according to the German Medicines Act (§14 AMG, corresponds to "Qualified Person" according to Directive 2001/83/EU Experience - Some years of experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products - Practical relevance to pharmaceutical manufacturing - Quality-conscious and systematic way of working as well as strong analytical thinking skills in risk assessment - Eligible to act as a Qualified Person for IMPs of biological and/ or immunological products, ATMPs (cell and gene therapy products),vaccines and/ or for commercial ATMPs. Knowledge, Skills, Abilities - Practical relevance to pharmaceutical manufacturing. - Quality-conscious and systematic way of working as well as strong analytical thinking skills in risk assessment - High customer and service orientation - Fluent in German and English What we offer - Employment with an innovative, future-oriented organisation - Outstanding career and development prospects - Company pension scheme and other fringe benefits - Exciting company culture which stands for integrity, intensity, involvement and innovation If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations. At Thermo Fisher Scientific, each one of our + 100,000 extraordinary minds has a unique story to Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of color, religion, ___ orientation, gender identity, national origin, disability or any other legally protected status. Apply today! Agency notice! Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.
Qualified Person (m/f/d) (Pharmazeut/in)