QA Complaint Co-ordinator

DUTIES & ESSENTIAL JOB FUNCTIONS

• Handling product complaints:initiating/receiving, processing and closing as per applicable standard operating procedures                                                                                  ·

• Interacting with the customer/reporter on a daily basis to acquire information that may be required to effectively investigate a product complaint

o    Analyzing the final investigations received from the manufacturing units to ensure accuracy

o     Initiating/following up with Vice President Notifications to ensure technical issues are being address

•  Following up with Corrective Action/Preventative Action plans to ensure technical issues are being address

• Accurately maintain product complaint logs (softcopy and hardcopy), and complete all filing and closing procedures

•  Scanning completed product complaint files and sending to respective departments as needed

• To initiate the revision of standard operating procedures and/or working instructions relating to product complaints

• To initiate and handle deviations related to product complaints, and inquiries, adverse drug events as deemed necessary

•  To assist in generating monthly, quarterly and annual metric reports

•  To assist in handling medicalinquiries, completing appropriate forms and providing answers when applicable

•  To assist in appropriately handling initial receipt of Adverse Drug Events {ADE) and processing it as per applicable

SOPs

• As deemed necessary, to assist in the handling and processing of field alert reports to the FDA

• Other projects, as deemed appropriate