Written procedures must be established and maintained for a quality system at the affiliate level to ensure compliance with applicable regulations and conformance to specified product requirements.
Quality Organization Responsibilities and Authority:
Approve or reject all affiliate quality related documents and records to assure that no errors have occurred or, if errors have occurred, that they have been appropriately investigated. The responsibility for product and material release is defined as per local requirement. Legally responsible for release of goods if defined in the Quality/Technical agreement.
Quality Manual & Audit Program:
A quality manual must be established and maintained and State how the Abbott Quality System is implemented at the affiliate.
A quality audit program must be established and maintained to independently appraise and oversee that the quality systems, including:
Abbott internal systems - Self inspection.
Exceptions, e. g. , deviations, nonconformities
Counterfeiting, Tampering, Diversion and Product Theft
Situations Corrective and preventive actions.
PQR Affiliate Certificate:
When affiliate is MAH & required by Reg. agency use appropriate form to certify annual product review
A change control process must be established, where required, to evaluate and control Changes, Revalidation/Periodic Review
Labels and artworks
Production Plan Submission & approval process management
Importation plan submission & approval process management
Commercial shipments clearance on CAPA level
Reconciliation of Safety Data-PV
Qualification & Experience:
3+ years of experience in similar position
MS office alert
Fluency in English ( written and spoken)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email Apply to send email to the employer