Lead Technical Documentation - Sisslerfeld Site Development (a) 100% — Bachem AG

Company and context

• Their tasks Setup Team Technical Authors and development of the organization as an internal service provider for production Development of an SOP landscape in cooperation with local and global interfaces Further development and harmonisation of document templates and standards to facilitate document creation Responsibility for writing, updating and optimizing manufacturing regulations (electronic MBPRs), SOPs, logbooks, risk analyses (FMEAs) as well as cleaning and process validation documentation for Bachem Sisslerfeld Ensuring formal and content document quality according to GMP and internal guidelines Creation and modification of Master Batch Records (MBRs) in the MES (PAS-X) in close cooperation with the producers Close cooperation with manufacturing and building a sound understanding of manufacturing processes, plants and processes Active participation in process coordination, shop floor visits and exchange with operators, production leaders, chemists and process engineers to ensure precise and practical documentation Compliance with all relevant GMP, HSE and compliance
• Requirements Ensuring the correct implementation of
• Requirements in manufacturing regulations, SOPs and risk analyses Support for internal and external audits by providing the relevant documents and information Active participation in strengthening the GMP and HSE culture in the team and production environment Your profile Completed studies in chemistry, pharmaceutical chemistry, biotechnology or a comparable discipline, ideally with a doctorate Several years of experience in the GMP-regulated pharmaceutical environment Leadership experience in building high-performing teams with the ability to foster ownership and engagement Ability to understand and describe complex chemical processes and technical relationships Interest in production-related GMP processes as well as in the creation and maintenance of GMP documentation.
• Enthusiasm for working on a project for the establishment of a new location, for the design of a phase-appropriate document landscape and for the continuation of the created structures beyond the project phases into daily operations Structured, precise and quality-conscious working methods with high standards of documentation and compliance Independent and solution-oriented working methods and the ability to develop pragmatic solutions even in complex or unclear situations Team-oriented personality with clear, open communication and ability to