Qualified Person
vor 2 Wochen
At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.- We know that our talented employees make STADA successful and help us grow and reach new achievements as a company. Therefore, alongside interesting work in diverse areas, we offer our employees a range of opportunities for professional and personal development as well as a working environment, which enables a healthy work-life balance.**Qualified Person (f/m/d) (Biologics)**
- Bad Vilbel | Deutschland (DE) | Vollzeit | Unbefristet**Main tasks, permanent activities and decision-making powers**:
- Performing the tasks as a qualified person according to - 14 AMG for the products manufactured and/or packaged by external contract manufacturers. The ability to release biosimilars according to -15 AMG is desirable but not a basic requirement as the product range includes biosimilars.
- Performing the duties of quality control manager for products manufactured and/or packaged by external contract manufacturers.
- Ensure that each batch of medicinal products manufactured by external contract manufacturers has been manufactured and tested in accordance with the regulations governing the circulation of medicinal products.
- Approving specifications, sampling instructions and testing instructions and ensuring that they are followed.
- Ensuring that all required testing is performed.
- Ensure that necessary validations of test procedures are performed (in collaboration with QA department and contract manufacturers).
- Ensure required initial and ongoing training of personnel working in the testing area.
- Continuous optimization and development of the whole area under the above mentioned aspects.
- Compliance with and monitoring of the applicable pharmaceutical legislation (e.g. AMG, cGMP, AMWHV, BtMG, etc.) in the area for which you are responsible (see 2)
- Processing of arising questions from the daily business
- Processing of deviations and test reports within the scope of the area of responsibility and OOS processing of specific questions within the scope of the area of responsibility
- Cooperation with other departments for the proper execution of business processes
- Organization of internal department documentation according to GMP guidelines
- Organization of the department, determination and review of the execution of the required scope of testing, taking into account the legal framework and GMP guidelines as well as economic efficiency and an optimization of processes.
**Your qualifications**:
- completed university studies in pharmacy, license to practice pharmacy or completed university studies in the natural sciences
- Expertise according to -15 AMG
- Good knowledge of the legal basics: cGMP, AMG, AMWHV
- Good knowledge in the field of pharmaceutical analytics
- Initiative and assertiveness
- Effective communication
- Analytical and systematic thinking
- Good command of English
- Good IT skills
- If you feel like this position is the one you were looking for, click on the “Apply” button.
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