Document writer

Werkzaamheden

• Technical writing of protocols and performing validations in collaboration with Subject Matter Expert (SME))
• Gather requirements, and/or user stories, specifications and write (URS, TM, FAT, IQ OQ, PQ.) for machines & equipment including the software component.
• Will be a subject matter expert GXP, GMP & CSV as it pertains to hardware equipment solutions within the medical device arena.
• You are very familiar with change control in a medical device environment and are capable and comfortable in leading validation activity from the creation of CR, URS, VP, etc incl. creating and execution of test protocols, Writing reports of protocol outputs. Up to the closure of VSR and CR.
• Communication with and support of other departments such as R&D, Quality Assurance (QA), Operations, External suppliers etc within the scope of work defined by the project deliverables.
• Implement new equipment validation in a way that enable seamless global scaling of those equipment and processes within our organisation.
• Design, develop and implement test plans, validation documents and be accountable for the delivery and completion of those activities.
• Analyze and assess product and process requirements (materials, process, quality, EHS, product specifications) and perform risk and root cause analysis
• Develop, improve and characterize design of products, processes, equipment, test methods and procedures and define requirements
• Organize engineering, validation and verification studies by setting up a test plan and protocol, test criteria, executing tests, analyzing, interpreting and reporting outcomes as well as identifying and solving technical issues.
• Plan, organize and evaluate the implementation process of new or modified products and processes, including writing standard operating procedures (SOP’s), protocols and procedures, risk assessments and training of employees.