Quality Assurance Document Control Specialist - Taiwan or Wuhan
Quality Assurance Document Control Specialist
· Performs QA Document Control functions, including document creation/review/modification/approval, login, tracking, processing, distributing and archiving.
· Coordinates the revision, review and approval of all GMP documents.
· Responsible for biennial Quality System review and update.
· Organises and ensures accurate and reliable filing systems for all paper-based GMP documents.
· Maintains electronic management systems and document processsing.
· Maintains Change Control, Deviation and CAPA processes for master batch records, specifications, test methods, validation protocols/reports and all other GMP documents and processes.
· Maintains in-house training programs, including training materials, training matrix and annual audit of training files.
· Serve as the primary source of contact for activities within QA Document Control.
Job Qualifications (Education, Certifications, Experience)
· BS degree, scientific discipline preferred.
· 2-5 years experience in a QA regulated industry, pharmaceutical or medical device experience is preferred.
· Excellent proficiency in the use of all Microsoft Office Applications and Adobe Acrobat Professional.
· Experience with an electronic document management system is a plus.
· Well organized and detail oriented professional, with strong verbal and written communication skills.
· Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
· Ability to effectively participate and communicate on multi-disciplinary teams.
· Knowledge of GMPs and related guidelines.