Comprehensive Product Management: Oversee the entire commercial lifecycle of the product, from its transfer by development to the present date, acting as the Single Point of Contact (SPOC). Risk Analysis and Quality Control: Create, update, and monitor the product-specific Quality Risk Analysis (QRA) and ensure compliance with quality standards. Data Monitoring and Analysis: Evaluate critical and key variables through statistical analysis, track data trends, and review the Annual Product Quality Review (APQR) to make informed decisions regarding control status. Performance Monitoring and Improvement: Deviation Management and Improvement Projects: Investigate process deviations, lead optimization projects, and engage cross-functional teams in improvement initiatives. In-Process Controls (IPC) Monitoring: Ensure the tracking of critical parameters in laboratories and guarantee that data is visible and communicated at the plant level. Process and Product Validation: Ensure continuous validation status, alignment with the APQR, and implementation of control strategies based on Critical Quality Attributes (CQA), Critical Process Parameters (CPP), and Critical Material Attributes (CMA). Facilitate product transfers by ensuring technical documentation and providing necessary support to the receiving plant. Manufacturing Optimization and Excellence: Lead improvement projects to enhance the robustness and sustainability of pharmaceutical processes in collaboration with Operational Excellence (OPEX).
University degree in a scientific field or related, or a higher vocational training degree in a scientific field with previous experience in a similar position. High level of English. Experience in a similar technical position and in the pharmaceutical sector. Knowledge of data management and application of statistical techniques.
Two days of home office per week Subsidized canteen on-site or restaurant ticket: to use when eating out or working from home Medical, life, and accident insurance Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a versátil, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D; material for clinical trial purposes to commercial production. Moreover, we produce 20 percent of global demand for caffeine.