Company Description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. 

Job Description

Job Summary

We are looking for an Associate, Quality Complaints who will play a pivotal role in maintaining and enhancing the quality complaints system. This role involves handling and processing complaints to ensure that our products meet regulatory requirements and exceed customer expectations.

Roles & Responsibilities

• You will be responsible for analyzing final investigations received from manufacturing and packaging units to ensure accuracy and completeness.
• You will assist in handling initial receipt of technical complaints and prioritizing respective partners.
• You will be responsible for evaluating CAPA (Corrective and Preventive Actions) effectiveness and offer recommendations to manufacturing and packaging sites to ensure effective prevention of issue recurrence.
• Your responsibilities include efficiently and accurately handling and processing complaint samples, and identifying critical complaints with potential for field alerts or recalls.
• Your role involves generating metric reports to track complaint volume, trends, and critical issues and updating management regarding market complaint issues.
• You will monitor and assist in assigning complaints, updating the complaints database, tracking investigation status, completing failure investigations, obtaining signatures, and generating responses to customers.
• You will be responsible for overseeing timely review of incoming product complaints and investigations to accurately capture all technical observations pertinent to the product complaint reporting process.
• You will propose strategies for improving complaint processing and cycle time, investigation processes, and customer response process.
• You will interface with Pharmacovigilance personnel and MICC to evaluate complaints for reporting them as MDR or ADE if applicable.
• You will be responsible for providing ongoing support for the complaint system, including process changes and qualification improvements where applicable.

Qualifications

Educational qualification: B.S. or M.S. in life sciences (preferred), or Bachelor’s in chemistry, biology, pharmacy, etc.

Minimum work experience: 5 years of experience in a GMP (Good Manufacturing Practices) setting of the pharmaceutical or medical device industry

Skills & attributes:

• Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH (International Conference on Harmonization) guidelines, FDA (Food and Drug Administration) guidance documents.

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Additional Information

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
 
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.