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

REQUIRED

• B.S. in a science related field an 2-3 year pharmaceutical experience in a quality/technical role

• Strong communication, customer service, and organizationa ski! s

• Must exhibit technical writing ability

• Must be a "go-getter" and exhibit a "can do" personality, and not afraid to bring on challenges

• Able to be efficient, multitask and work independently

• Skill to record the information received promptly and correctly on the appropriate documentation form is a must

• Should be proficient in using Microsoft Office (Excel, Word, Powerpoint, Outlook, etc)

PREFERRED

• Prior Pharmacovigilance/ADE/product complaint handling experience

All your information will be kept confidential according to EEO guidelines.