Quality Specialist III

Watson Pharama

1 - 8 years

3 - 10 Lacs

bengaluru

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Skills Required

team management operational excellence lms pharma pharmacy reconciliation packaging life sciences continuous improvement recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

The opportunity

Is responsible receiving, categorizing, trending, logging complaints for US market and coordinating the return of the complaint Samples for product quality related complaints from customers.
This includes handling of complaints reported by US customers (patient, doctors, pharmacist, HCP or any other customers who use or handle Teva products) via live phone call (90%), email and voicemail etc.
QAS team member need to be logged in Avaya Phone application between 6:30 PM IST (9:00 AM EST) to 2:30 AM IST (5:00 PM EST) to receive live phone calls related to complaints handling from US customers.
The received complaints are processed in TrackWise application including classification into multiple categories (critical/non-critical) and also sending notifications to respective manufacturing /packaging sites located globally requesting investigation.
Additional responsibilities include completion training in LMS (QAS process related) and STUDIUM tasks, handling reconciliation activities related to PV, complaint samples returned and participate in team meetings.
Phone Etiquettes and Customer Service Skills:
1. Positive Customer relationships with productive interactions related to Complaint issue, Gain better understanding of the issue, obtaining more information. Provide update on investigation status. Coordinating and checking the availability of Complainant Sample for return to investigating sites 2. Providing excellent customer service by providing product replacement in related to product quality complaints reported, while maintaining Teva s principles and compliant practices. 3. Strong communication skill in English language 4. Patience and Empathy towards customers 5. Attention to detail and problem-solving skills 6. Multitasking ability

How you ll spend your day

Complaint Processing:
Performs the functions associated with receiving, trending, logging, and coordinating the return of the complaint samples for product quality related Complaints. This includes complaints received via live phone call, 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 team to discuss and calibrate on different complaint scenarios on how records should be handled during weekly team meeting.
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.

Your experience and qualifications

Bachelor of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Life sciences, etc.
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.

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