Description
Complaint & Vigilance Analyst: cGMP, Pharmaceuticals, QA
My client, a world renowned pharmaceutical organisation located near Antwerp, Beligium is seeking a Complaints and Vigilance Specialist to process and analyse product complaints to policies and Standard Operating Procedures.
The successful candidate will be expected to:
Possess knowledge of cGMPs, regulations and risk management requirements to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System.
This may include but is not limited to, review of the event reported, determination of the defect category, MDR reportability, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable
* Exhibit strong communication skills in order to collaborate with Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc.) to ensure appropriate complaint handling.
* Deliver appropriate training to complaint management system end users.
* Works independently, challenges the status quo, identifies gaps and process improvements.
* Participates within special projects
* Maintain and update applicable department procedures via the Document Management System