How you’ll spend your day
Complaint Processing:
Performs the functions associated with receiving, trending, logging and coordinating the return of the Samples for product quality related Complaints. This includes complaints received via phone, email, and internet. Utilize knowledge and experience from processing of live complaint calls to lead by example
Assists QAS Intake team management in handling of QAS Intake team activities
Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions. Collaborate with QAS Daily review team and/or closing team to discuss and calibrate on varying views on how records should be handled
Responsible for handling High Profile complaints. Conduct a day end review to ensure that proper justification is provided for and documented in all High-Profile complaint
Participate and contribute to the continuous improvement activities of the QAS group
Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group
Tasks and Projects may include but are not limited to:
Support audits and inspections of QAS group
Provide data related to product complaints, volumes, Deviation reports as required
Identify automation and defect proofing opportunities and highlight the same to QAS management via business cases, quantifiable data
Voice process (Incoming and outgoing calls to various customers of Teva)
Your experience and qualifications
Minimum 1-4years of overall experience in handling Complaints
Bachelor’s degree of Pharmacy (B. Pharm) or Master’s Degree in Pharmacy (M. Pharm) and also MSC if candidate is fitting in criteria required
Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA; Data Integrity and TrackWise but not mandate
Excellent written and verbal communication skills in English Language
Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)
Availability to take phone calls with external customers continuously during the US business hours
Experience from regulated market preferred
Shift: Night Shift (6 PM to 3 AM)
Hybrid Working (3 Days working from office and 2 days working from home)
