Ensure implementation of the below requirements (as applicable):
Quality System:
* Establish and maintain the written procedures for a quality system at the affiliate level to ensure compliance with applicable regulations and conformance to specified product requirements.
* Ensure that the affiliate incorporates the system requirements defined in Abbott policies into their quality system.
Quality Organization Responsibilities and Authority:
* The affiliate CDQA manager must have the responsibility and authority to 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 quality authority should not be delegated to other function
Management Review:
* Conduct the Management Reviews quarterly, however Additional Management Reviews can be performed at any time during the year, if necessary.
Quality Manual
Establish and maintain A quality manual and State how the Abbott Quality
System is implemented at the affiliate.
Quality Audit Program
* Establish and maintain A quality audit program to independently appraise and oversee that the quality systems, including:
* Audit Readiness.
* Abbott internal systems - Self inspection.
o External suppliers of materials and services
o Affiliate to notify Region QA by any external audit and to ensure the
procedure is implemented
Complaints Handling:
* Non-medical complaints and medical complaints with potential quality implications including a review of all received non-medical product complaints open/aging status and analysis based on complaint criticality.
Quality Events Handling:
Ensure the procedure is implemented and maintained for the following:
* Exceptions, e.g., deviations, nonconformities
* Product Actions
* QA Holds
* Significant events
* Counterfeiting, Tampering, Diversion and Product Theft
* Situations Corrective and preventive actions.
Supplier Management:
* Ensure that the procedure is implemented and maintained.
Material Control:
* Ensure that the procedure is implemented and maintained.
Vaccine Procedure:
* Ensure that the procedure is implemented and maintained.
Risk Management
* Use risk management tools in different parts of the quality system to provide consistent and effective outcomes.
Employee Training:
* Personnel that perform or oversees GXP (GMP, GCP, GLP) related activities such as approval, investigation, complaint handling, compliance auditing, training, servicing, purchasing and distribution of the product.
* Maintain related records - Training Curriculum, Training attendance
Change Control:
* Establish the change control process, where required, to evaluate and control Changes, Revalidation/Periodic Review
* Document change control
* Labels and artworks change control
Reconciliation of Safety Data-PV
Quality Assurance Manager Requirements:
* Degree in a related field.
* ASQ certification.
* 5 years of experience working with quality systems and preferable in a similar position.
* Proficiency in Microsoft Office and quality management systems.
* Excellent communication, interpersonal, and public speaking skills.
* Excellent decision-making and problem-solving skills.
* Strong organizational skills
* Good command of English language
* Mobile, open to travel and back up other affiliates within ESL cluster