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Mô tả công việc
JOB SUMMARY
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.
ESSENTIAL DUTIES
• 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 VCCR's 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.
Yêu cầu
Education
Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
Preference 2 years experience with Terumo BCT disposable manufacturing processes, documentation, and procedures.
Skills
• Fluent and good command of both English and Vietnamese languages.
• High proficiency with software utilized in the creation and maintenance of engineering documentation: MS Word, MS Excel, Adobe Acrobat, MS Publisher and MS Visio.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Excellent spelling, grammar and math skills.
• Ability to interpret, carry out and enforce company policies and procedures.
• Excellent organizational skills and demonstrated attention to detail.
• Ability and willingness to adapt to work interruptions, changing priorities, and manage a diverse workload.
• Ability to perform in a team environment as well as individually.
• Strong detail orientation and ability to review and error-check a wide variety of technical documents.
• Maintains basic knowledge of company products, manufacturing processes.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Time management
Quyền lợi
Health Care for associate & family
Training route in US, Japan or other countries (if any)
Transportation (from HCMC, Bien Hoa, Binh Duong)
Thông tin chung
- Ngày hết hạn: 17/04/2019
- Thu nhập: Thỏa thuận
