Quality Assurance Specialist (Pharmaceutical) | Chemiker (m/w/d)
AMCAPHARM Pharmaceutical GmbH
Job Summary
Join AMCAPHARM Pharmaceutical GmbH, a contract manufacturer of pharmaceuticals for the German, European, and international markets, specializing in suppositories and liquids. This part-time role (up to 30 hours) is a parental leave replacement within Quality Assurance Management. The specialist will be crucial in maintaining and advancing the Quality Assurance (QA) system, including quality risk management, and actively participating in implementing the EU GMP guidelines. Day-to-day tasks involve creating and maintaining quality documentation, qualifying equipment and suppliers, and managing inspections and audits from authorities and customers. The ideal candidate holds a Bachelor's degree in Chemistry or Biology (or equivalent qualification/training) and possesses strong organizational skills, meticulous attention to detail, and a high sense of responsibility for quality standards. Good English skills and proficiency in MS Office are required to handle correspondence and documentation effectively.
Required Skills
Education
Bachelor's degree in Chemistry, Biology, or comparable field; alternatively, completed training as a Medical Documentation Assistant, Pharmaceutical Technical Assistant (PTA), Chemical Technical Assistant (CTA), or comparable qualification.
Experience
- Professional experience in monitoring and developing QS systems (Quality Assurance Systems)
- Experience in implementing EU-GMP guidelines
- Experience in preparing for and supporting authority inspections and customer audits
Languages
Additional
- Part-time position (up to 30 hours); Parental leave replacement.