Quality Specialist

Job Description

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are 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) Sr Mgr Commercial Quality Teva s Equal Employment Opportunity Commitment