Halle (Westfalen), Germany
€60,000 - 70,000
5 months ago
We are currently working very closely with a leading biotechnology organization who develop oncology products. Due to a large amount of increase in product demand and an increase in productivity, they are looking for a number of Quality Assurance Specialists to join their ever-expanding team.
They are looking for someone to be responsible for acting as direct support for general GMP queries, as well as being responsible for incoming customer enquiries from the QA department with appropriate feedback to our customers falls into the scope.
Other responsibilities include:
- Support and coordination of QA-related topics to prepare FDA PAI inspections
- Review of master batch records during the validation phase and product-specific SOPs / documentation and validation documents
- Ensuring compliance GMP standards for new manufacturing processes
- Accompanying GMP-critical manufacturing steps according to customer requirements
- Supporting customer visits in the production area, explaining the GMP processes and answering GMP-related questions
- Explanation of the quality standards and procedures before external visitors and during telephone conferences
- Degree Qualified within a Scientific or related discipline (Chemistry, Pharmacy, Biotechnology)
- 5 years experience in the pharmaceutical industry
- 3 years experience in quality management of medicines
- Knowledge of the GMP guidelines and their interpretation
- Knowledge of aseptic / sterile production
- Business fluent German and English
Hamlyn Williams are a specialist recruitment agency within Quality Assurance. If this is something that you would be interested in, please apply now and one of our consultants will reach out to discuss further!