Mô tả công việc
Independently performs difficult, complex, and highly specialized documentation work, as well as high level coordination
required to maintain the accuracy, completeness, and integrity of the TBV’s process engineering documentation.
• Gather input, support execution, create and coordinate the review/approval of validation documentation such as Installation Qualification, Operational Qualification, Product Qualification and Validation Summary Reports.
• Review engineering documents for accuracy, formatting, internal consistency, and compliance with Company standards.
• Review and revise documents or related stuff based on engineering change orders, and reports for accurate or updated content, proper grammar, spelling, and accurate revision history..
• Coordinates approval of change orders with originators, approvers, and QMS associates in order to ensure timely processing that meets business needs and complies with the QMS.
• Provide mentoring and coaching to personnel who is affected or related with documents; train new and junior engineers in the Company’s change order, validation processes and general documentation system.
• Perform administrative clerical work as well as work that is non-clerical in nature and that is difficult, complex, and highly specialized.
• Evaluates VCCRs for impact on design control documents, risk management documents and process validations.
• Interface with Terumo BCT Ltd Northern Ireland and Lakewood, CO, on changes affecting processes that cross between Lakewood, Larne and Fujiyama products.