Complaints Handler - Planet Pharma : Job Details

• MUST be strong with Excel, Word, Sharepoint
• Knowledge and experience using Electronic Quality Management System (OMNIFY) is helpful but will be taught so not required.
• Is this post-market complaint handling - YES
• Education - college degree OR experience in complaint handling - both preferred
• Ideally some experience working with medical device product - DEVICE

Duties:

• Regularly monitors Complaint Handling inbox for new complaints and adverse event reports
• Generates complaints in the eQMS and adds data inputs to Master Complaint Tracker
• Attaches all relevant files and reports for the complaint to the eQMS e.g. PC/AE reports, Follow-Up communications, Reportability Assessments, log files etc.
• Organizes and generate Complaint folders in SharePoint to help with investigations and collaboration activities
• Performs DHR review for Complaint investigations
• Updates Complaint investigation summary with administrative information including complaint number, PC/AE report information, Device information etc.
• Creates- log files and attaches to the eQMS and SharePoint Complaint folder
• Monitors Handpiece returns inventory and places weekly requests with 3PL for return shipments

Skills:

• Knowledge of QSR's and their application
• Complaint handling experience
• Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
• Ability to manage multiple responsibilities with a high degree of self motivation
• Good written, oral, and interpersonal English communication skills
• Ability to use Microsoft Word and Excel applications

Education:

• Minimum 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience