/ EN


Quality Assurance Document Control Specialist - Taiwan or Wuhan


Quality Assurance Document Control Specialist 

Job Responsibilities

·         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.