Lead Associate Quality Complaints

Job Description

North America business group seeks to hire Lead Associate Quality Complaints, based in Hyderabad office, the incumbent will play a pivotal role in maintaining and enhancing the quality complaints system. This individual will be responsible for handling and processing complaints to ensure that our products meet regulatory requirements and exceed customer expectations.

Responsibility:

• Analyzing the final investigation received from the respective manufacturing and packaging units to ensure accuracy and completeness
• To assist in appropriately handling the initial receipt of technical complaints and triaging the respective partner
• Handle & Process complaint samples efficiently and accurately
• Assess the CAPA effectiveness and provide recommendations for the manufacturing and packaging sites to ensure that all corrective and preventive actions are effectively preventing the recurrence of identified issues
• Identification of critical complaints that have the potential to cause Field Alerts or recalls
• Creation of metric reporting to track complaint volume, trends and critical issues in order to update management on the market complaint issues
• Monitor and assist with assigning complaints, updating the complaints database, tracking complaint investigation status, assisting in the completion of failure investigations, obtaining signatures, generation of responses to customers
• Oversee the effective and timely review of incoming product complaints and Investigations to ensure that all pertinent technical observations are accurately captured with respect to the product complaint reporting processes
• Suggest strategies to improve complaint processing cycle time, customer complaint processing, investigations and/or customer response processes
• Interfaces with the Pharmacovigilance personnel and MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE
• Interfaces with MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE
• Ongoing support of complaint system (changes to processes, and qualification where applicable).

Qualifications

Bachelors. B.S. or M.S. in life sciences is preferred; chemistry, biology, or Pharmacy etc.

· A minimum of 5 years’ experience in a GMP setting of the pharmaceutical or medical device industry, particularly in complaints management

· Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, DSCSA, and FDA guidance documents

Additional Information

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

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.
For more details, please visit our career website at https://careers.drreddys.com/#!/