Senior/Principal – Complaint Management QA
Company: Eli Lilly and Company
Location: Hyderabad, Telangana, India
Job Category: Manufacturing / Quality
Job Type: Full-Time
Job ID: R-102315
Experience Required
Minimum 3+ years of industry experience in areas such as Quality Assurance, Engineering, Product Development, or Manufacturing/Packaging within the pharmaceutical, biotechnology, or medical device industry.
Education
Bachelor’s degree in Engineering, Medical Sciences, Life Sciences, or a related scientific discipline is preferred.
Job Overview
Eli Lilly and Company is seeking a Senior/Principal Complaint Management QA professional responsible for supporting quality systems related to medical devices and drug-device combination products. The role focuses on complaint investigation review, device safety surveillance support, and ensuring compliance with global regulatory and quality standards.
The position requires collaboration with cross-functional global teams to manage complaint handling processes, analyze trends, and contribute to quality improvement initiatives that enhance product performance and patient safety.
Key Responsibilities
Review and approve complaint investigations for medical devices and drug-device combination products.
Initiate and support investigations including trend analysis, root cause investigations, review management, deviations, and change management activities.
Conduct complaint history reviews to identify recurring issues and potential quality trends.
Compile and document ad-hoc reports related to complaint management activities.
Develop a clear understanding of devices and drug-device combination products to support investigations according to company procedures.
Support activities related to device safety surveillance for medical devices and combination products.
Collaborate with internal and external teams including regional centers, international affiliates, global patient safety teams, and suppliers when required.
Review, draft, and approve GMP documentation including SOPs, training materials, global procedures, technical reports, and process-level documentation.
Support continuous improvement initiatives and quality activities associated with new product launches.
Participate in technical projects requiring strong analytical skills and quality expertise.
Use internal systems and analytical tools to collect data and generate metrics related to complaint trends and process performance.
Verify action records, effectiveness checks, and implementation reviews.
Conduct second-person verification of reports when required.
Identify opportunities to improve complaint handling processes and share best practices with internal teams and business partners.
Required Skills and Knowledge
Technical knowledge of device design, manufacturing processes, or validation activities is preferred.
Strong understanding of complaint handling processes and quality management systems.
Knowledge of regulatory requirements such as cGMP, 21 CFR Part 820, ISO 13485, and Canadian MDR.
Strong computer proficiency in Microsoft Outlook, Word, and Excel.
Excellent English communication skills, both written and verbal.
Strong technical writing capabilities.
Preferred Skills
Basic knowledge of statistics and its applications in quality and process improvement.
Ability to compile data and present metrics in reports suitable for management and business stakeholders.
Strong attention to detail, analytical thinking, and problem-solving abilities.
Ability to mentor team members and manage responsibilities independently.
Equal Opportunity Employer
Eli Lilly and Company is committed to creating an inclusive workplace and providing equal employment opportunities to all qualified candidates regardless of race, religion, gender, sexual orientation, disability, veteran status, or any other protected characteristic under applicable laws.
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