Description
The QA Product Complaint Specialist is responsible for maintaining the product quality complaint electronic system, managing the overall product quality complaint process, developing appropriate PQC (product quality control) metrics and ensuring that the complaint management process is compliant with GXP requirements.Experience:
* Minimum of 4 years experience in a QA/compliance related position within the pharmaceutical/biological industry
* Demonstrated track record of identifying and correcting compliance issues and implementing process improvements
* Proficiency in scientific writing
* Minimum 5 years experience with compliance management.
Skills:
Coordinate and manage the product complaint system/process including:
* Complaint intake;
o Evaluations of records to determine if the information meets the definition of a complaint, adverse event, or inquiry under applicable SOPs
* Managing investigations with the CMO/Supplier including;
o Review investigation results;
o verification results of corrections
* Close out of the complaint. Including:
o Review complaint records for completeness
o ensure complaint records are properly documented
o including ensuring complaints are properly closed per SOPs; and
o providing appropriate response to the complainant
To find out more about Real please visit www.realstaffing.com