Training and Documentation Specialist
vor 2 Wochen
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. If you are passionate about applying your expertise to optimize drug product manufacturing and truly make a difference, we encourage you to explore this opportunity. Key responsibilities: Acts a change agent, who is supporting and promoting overall changes in Drug Product department, with a particular focus on the following training activities: Responsible for training activities of operators and scientists within the local training infrastructure as well as inside the global Lonza Biopharma network. Liaises with operations team to ensure training programs align with quality and business goals and support functional objectives. Supports developing training strategy and programs as well as related material to suit training of different levels, including development of trainers. Provide training in classroom and shopfloor settings, including assessment of trainees’ competencies and qualifications. Writes and/or adapts department specific SOPs in the area of expertise. Perform other duties as assigned as part of the documentation specialist team: Executes manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution. Supports to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) specific to the assigned production area. Reviews production documentation and works on deviations, change requests and implementation of CAPAs to ensure high-quality GMP standards. Key requirements: Studies in Pharmaceutical Technology/ Chemistry/ Pharmacy Experience in MES recipe authoring, preferably in Emerson Syncade Process knowledge in the area of sterile drug product is advantageous Knowledge of DeltaV is preferable Familiar with working in regulated environment, knowledge of cGMP, 21CRF part 11 and validation requirements Proficient in both German and English is an asset Familiarity with GMP requirements, quality procedures and SOP execution Good interpersonal skills and interaction with a variety of interfaces within the organization and on the shopfloor Structured, focused and well-organized working demeanor Motivated and driven; with a problem-solving attitude Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R71285
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Training and Documentation Specialist
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