Primary resource for development, execution, review, and approval of equipment qualification (including TCUs, laboratory equipment, and computerized systems), change controls.
Author, review, and approve technical documentation, protocols, and reports. This includes but is not limited to IQ/OQ/PQ protocols, change controls, and SOPs.
Supports equipment qualification and requalification: computerized laboratorysystems, processing equipment, temperature controlled units, etc.
Stays current with changes to GMP, including FDA, EU, and other regulatorybodies as well as guidance documents (i.e. ICH, ISPE, GAMP, ISO, etc)
Interact frequently with laboratory, manufacturing, facilities to provide expertise onequipment qualification. Address conditions/practices with appropriate personnel;report findings to Management.
Participate in quality and process improvement initiatives and project teams.
Participate as needed to support Client and Regulatory audits.
Works on routine assignments per written procedures; ability to recognizedeviation from accepted practice.
Ability to work in a team environment and independently as required.
Normally receives minimal instructions on routine work and detailed instructions on new assignments.
3 or more years of relevant experience or equivalent
Bachelors' degree in a Science related field or equivalent experience
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.PI134522310