Documentation & Systems Specialist
We are seeking a bright, enthusiastic and motivated Documentation & Systems Specialist, ideally with experience in a fast pace environment to join a growing team and support the development of a next generation personalised cancer medicines. The role is based in Zug and is a great opportunity to play an active role in transforming medicine
- Update existing standard operating procedures, work instructions, and GMP training material to align with new processes and system functionality. When needed, support development in new procedures and work instructions.
- Create and manage document workflows, including review and approval processes, in the document management system.
- Develop and revise training materials including virtual Instructor Led training and eLearning.
- Review and approve requests for access to the PLM system, including confirmation that appropriate training requirements have been met. Coordinate and execute the quarterly User Entitlement Review for Oracle Agile PLM.
- Coordinate and support PLM User-based global forum for identification of continuous improvements, system enhancements, and overall roadmap strategy for Oracle Agile PLM
- Support or lead continuous improvement projects by means of project coordination and follow-up. Provide support for performing analyses and solution identification.
- Ensure compliance by monitoring timely closure of deviations, corrective/preventive actions (CAPA), and audit observations related to Oracle Agile PLM system and business processes. Perform investigations for deviations to determine root causes and implement CAPAs.
Skills and Requirements
- Bachelor's Degree or University Apprenticeship
- Experience in a regulated environment (pharmaceutical or medical technologies, space or air industries etc.) is a plus, but not required.
- Excellent organizational skills with strong attention to detail
- Experience using eLearning training development software (such as Articulate Storyline).
- Strong writing, editing, MS PowerPoint and graphic design skills
- Knowledge of Oracle Agile PLM is a plus.
- Strong customer focus & communication skills
- Strong analytical, technical, problem solving, and data management skills
- Flexibility and ability to work in teams
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +443300524502 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies