Job details
Job type full-time
Full job description
Location: remote
Position: quality assurance auditor
Job responsibilities:
Cmo/vendor audit activities which includes:
Perform vendor audits of existing and new cmo/cpo/ctl/vendors
Preparing/review/approval of audit reports and carry out follow-ups regarding audit report response from cmo/vendors and ensure adequate implementation of proposed capas by cmo/vendors.
Ensure that cmo/vendor audits are carried out per audit schedule
Review quality agreements with cmo and vendors
Reviewing cmo qms documents like deviations, investigations, protocols, change controls, process validation, etcIf required
Collection of vendor-specific documents like gmp and debarment certificate, latest eir, regulatory accreditation, sop list, instrument list, site master file / quality manual etcFor reference.
Maintain vendor audit response tracking spreadsheet
Support regulatory inspections (fda, vawd, nabp, etc.)
Handle/carry out other qa related activities/projects as assigned by supervisor
Glenmark pharmaceuticals inc usa is proud to be an equal opportunity workplace and is an affirmative action employerWe are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.
Job type: full-time
Work location: multiple locations
