Quality auditor

Job Description

The Quality Specialist supports the Quality Systems activities in both Drug Substance and Drug Product facilities.

* Ensures timely completion of Quality Systems core functions according to Ballydine schedules and MMD policies, procedures, and guidelines.
* Provides leadership on validation standards for Drug Substance and Drug Product pharmaceutical facilities.


Responsibilities


Sub System Ownership:

* Completes sub system ownership responsibilities as per site System Ownership list.
* Quality SME for Process, Cleaning, Water, Equipment.


Quality Agreement System Management:

* Ensures Quality Agreements are current, approved, and retrievable.


Annual Review System Management:

* Completes reviews to meet Annual Review schedule.


Creation, Review, and Approval of Site Quality Documentation:



Quality Oversight:



Supplier Change Evaluations:



Filing & Licence Maintenance and Regulatory Requests Follow-ups:



QA Regulatory Data:



Audit Program:



Special Features



Experience, Knowledge, and Skills


Technical:



Business:



Leadership: