layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Sr QA Supplier Specialist at Fresenius Kabi

Facilitates activities associated with supplier management program and supports qualification of new and existing suppliers
Collaborates with cross-functional groups to complete supplier (re)qualification activities
Interfaces with suppliers for audits (on-site, virtual, hybrid, or document) and requests (re)qualification documentation
Performs supplier (re)qualification audit
Collects and reviews supplier (re)qualification documentation
Prepares supplier (re)qualification reports or assessment/evaluation reports
Updates and maintains regional (US QA Compliance) supplier tracking databases. Updates global supplier tracking databases
Assists team members with supplier qualification activities as needed
Supports local, regional, and global departments with their questions/requests relating to suppliers
Manages and maintains Approved Vendor List
Facilitates activities associated with Regional internal audit program
Assure internal audits are scheduled, conducted, and closed
Participates in internal audit as a Lead or Co-auditor
Plans, prepares, and conducts internal audit
Collaborates as Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure
Interface with auditees
Updates and maintains internal audit tracking database
Facilitates activities associated with Quality Agreement
Executes or supports supplier quality agreement according to defined business relationship with suppliers
Executes or supports inter-company quality agreement according to defined business relationship with other non-FK USA entities
Collaborates with cross-functional groups and/or suppliers to draft, review, and/or finalize quality agreement
Performs periodic review of executed quality agreements and execute action(s) based on the review outcome
Updates and maintains regional (US QA Compliance) Quality Agreement database
Updates global Quality Agreement database
Assist with preparing monthly management review presentation
Prepares monthly supplier data for product APQR as requested from Production Units
Assists team members in supporting internal, external, customer, and regulatory inspection, as needed.
Supports maintenance or process improvement of programs for supplier management, internal audit, and quality agreement, as needed

Sr QA Supplier Specialist

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