Publicerade inlägg i: Övriga Jobb i Texas | Posted: |
Job Description
POSITION SUMMARY:
This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Supports process improvements implementation.
POSITION RESPONSIBILITIES:
Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
Provide final QA approval on simple change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
May also review and approve documents such as Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changes.
Capable to Make quality decisions in real time according to regulations and procedures.
Ability to work collaboratively with internal partners to resolve technical issues.
Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.