Quality Analyst Iii

1-4 years

Not Disclosed

Bangalore India

10 Feb. 12, 2025

Job Description

Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Specialist III
Date: Feb 7, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 60616

Company Overview

At Teva Pharmaceuticals, our mission is to make good health more affordable and accessible, improving the lives of millions worldwide. As a leading manufacturer of generic medicines, we supply products featured on the World Health Organization’s Essential Medicines List. Our medicines help over 200 million people globally every day. Join us in continuing to make a meaningful difference in healthcare.

Job Responsibilities

Complaint Processing
- Manage the processes related to receiving, trending, logging, and coordinating the return of product samples for quality-related complaints.
- Handle complaints received through various channels such as phone, email, and the internet.
- Lead by example in processing live complaint calls.
Support to QAS Intake Team Management
- Serve as a Subject Matter Expert (SME) on all In-Take Team complaint processes and scenarios.
- Ensure compliance with Quality Assurance Services (QAS) Standard Operating Procedures (SOPs) and Work Instructions.
- Collaborate with the QAS Daily Review Team and/or Closing Team to ensure proper handling of records and provide justification for actions taken.
High Profile Complaint Management
- Oversee the handling of high-profile complaints, ensuring that proper documentation and justification are provided.
- Perform day-end reviews of high-profile complaints for accuracy and completeness.
Continuous Improvement Activities
- Contribute to the continuous improvement of the QAS group by driving operational excellence.
- Perform tasks and projects aimed at improving compliance, efficiencies, and effectiveness within the team.
- Support audits and inspections of the QAS group and provide relevant data related to product complaints, volumes, and deviation reports.
- Identify automation and defect-proofing opportunities and communicate them to QAS management with supporting data.
Voice Process
- Engage in incoming and outgoing calls to Teva customers, ensuring effective communication and resolution of product-related complaints.

Qualifications

Education:
- Bachelor’s degree in Pharmacy (B. Pharm) or Master’s degree in Pharmacy (M. Pharm) or M.Sc.
Experience:
- 1-4 years of experience in complaint handling in a regulated market.
Knowledge and Skills:
- Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP).
- Familiarity with product quality-related complaints, adverse events, deviations, investigations, root cause analysis, CAPA (Corrective and Preventive Actions), and data integrity.
- Experience with TrackWise (preferred but not mandatory).
- Excellent verbal and written communication skills in English.
Other Requirements:
- Ability to work in a night shift (6:30 PM to 2:30 AM IST).
- Flexibility to take phone calls with external customers during US business hours.
- Availability to work in a hybrid setup (3 days in the office, 2 days from home).

Reports To

Associate Director, Commercial Quality

Already Working at Teva?

If you are a current Teva employee, please apply through the internal career site available on "Employee Central." Your application will receive priority, and you’ll also gain access to exclusive opportunities for Teva employees.

For any issues accessing your EC account, please contact your local HR/IT partner.

Teva Pharmaceuticals is committed to equal employment opportunities and creating a diverse and inclusive workplace. We welcome individuals of all backgrounds to apply and provide accommodation if needed throughout the recruitment process. All accommodation details will be kept confidential to ensure an accessible candidate experience.

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Quality Analyst Iii

Job Description

Company Overview

Job Responsibilities

Qualifications

Reports To

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