Villars-sur-Glâne, Fribourg, Switzerland
• Lead qualification of manufacturing, packaging, utility, and QC equipment, as well as computerized systems (DQ, FAT, SAT, IQ, OQ, PQ), ensuring compliance with Validation Master Plan • Define URS and develop all qualification/technical documentation (protocols, risk assessments, instructions, configurations, and operational settings) • Manage equipment lifecycle: change controls, deviations, non conformities, and CAPAs • Conduct technical tests and support introduction of new equipment, technologies, and system upgrades • Perform periodic qualification reviews and ensure continuous technology monitoring • Lead production investigations for equipment or process related issues using advanced RCA tools (5M, 5WHY, 8D) • Coordinate internal teams and external suppliers for validation and engineering projects, including timelines and budget tracking • Contribute to site projects (e.g., new product introduction, customer requests)
• Execute and supervise the manufacturing of pharmaceutical batches in compliance with GMP and production requirements • Develop, optimize, and scale up production processes to improve robustness and efficiency • Perform routine equipment checks, maintenance coordination, and manage qualification activities • Create, revise, and manage Master Batch Records and production documentation • Lead deviation investigations related to production operations and implement CAPAs • Ensure compliance of production quality documentation, including change controls and risk assessments • Manage projects (e.g., extractables & leachables procedure implementation)
• Management of different projects in collaboration with industrial partners active in the ink industry • Scale up of nanoparticle synthesis up to 15L, characterization by electronic microscopy (TEM, SEM) and spectroscopic analysis (UV, IR, DLS, MP-AES) • Creation of risk analysis, standard operating procedures, cost analysis and technical documents • Development of a contactless conductimetric detection system (C4D) • Design of a rubber tile manufacturing system for tire recycling in Rwanda and management of the technology transfer