Quality Assurance Officer for API Manufacturing | Qualitätsbeauftragter (m/w/d) für die API-Herstellung in Vollzeit
WIELAND Edelmetalle GmbH
Job Summary
As a Quality Assurance Officer for Active Pharmaceutical Ingredient (API) production, you will be responsible for the establishment, maintenance, and continuous improvement of the GMP quality system. Your daily activities involve ensuring compliance with GMP, GLP, and DIN ISO standards directly on the production floor, as well as releasing pharmaceutical ingredients for the global market. You will lead internal and external audits, manage deviations and CAPAs, and provide essential training to staff on quality topics. This role is highly collaborative, requiring close interaction with production and analytical teams to drive process improvements. This position is particularly attractive for professionals looking to work in a tradition-rich yet innovative environment within the successful SAXONIA Group, offering a mix of operational 'hands-on' quality management and strategic oversight in a highly regulated pharmaceutical environment.
Required Skills
Education
Completed technical or scientific training or degree, ideally in the field of Chemistry (Apprenticeship, Bachelor, Master, or equivalent).
Experience
- Several years of professional experience in quality assurance within a regulated environment (e.g., GMP, Medical Devices, or DIN ISO).
- Experience in conducting or supporting audits and regulatory inspections is preferred.
- Proven experience in handling quality-related documentation and compliance issues.
- Professional experience in a production-oriented or 'hands-on' environment.
Languages
Additional
- Occasional travel required. Must demonstrate a high level of reliability and the ability to work independently within a production environment.