Quality Specialist III

Tevapharm; Bengaluru; Hybrid; INR 5,00,000 - 8,00,000; Full time

Job summary

A leading pharmaceutical company in Bengaluru is seeking a Complaint Handling Specialist. In this role, you will manage complaint processes and ensure compliance with Quality Assurance standards. Candidates should have a Bachelor's degree in Pharmacy and 1-4 years of experience in complaint handling. The position requires excellent communication skills in English and flexibility to work in night shifts, with a hybrid working model. Join us to make health affordable for many.

Qualifications

• 1-4 years of experience in Complaints handling.
• Understanding of US Regulations and Good Manufacturing Practices preferred.
• Experience from regulated markets is a plus.

Responsibilities

• Process and manage complaint data from various sources.
• Act as a Subject Matter Expert for complaint processes.
• Participate in continuous improvement activities for QAS.

Skills

Complaint handling

Communication skills in English

Flexibility to work night shifts

Education

Bachelor’s degree in Pharmacy

Master’s Degree in Pharmacy

Tools

TrackWise

Job description

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.

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 complaints.
• 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 customer's of Teva)

Your experience and qualifications

• Minimum 1-4years of overall experience in Complaints handling,
• 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)

Reports To

Associate Dir Commercial Quality

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.