Job Title: Quality Assurance Principal Associate
Location: Hyderabad, Telangana, India
Category: Manufacturing/Quality
Job Type: Full-Time, Regular
Job ID: R-84518
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader dedicated to:
Delivering life-changing medicines
Improving understanding and management of diseases
Supporting communities through philanthropy and volunteerism
We prioritize people first and seek individuals committed to high-quality work and operational excellence.
Role Overview
The Quality Assurance Principal Associate (PIP – Person in Plant) supports all quality activities within Lilly’s Active Pharmaceutical Ingredient – External Manufacturing (API-EM) organization. Based in Hyderabad, this role ensures that all batches meet specifications, are manufactured according to validated processes, and comply with cGMPs and regulatory commitments.
The position involves frequent interaction with external partners, internal team members, and site management. Travel to Visakhapatnam (Vizag) may be required.
Key Responsibilities
Quality Oversight & Compliance
Serve as the primary liaison between Contract Manufacturers (CMs) and Lilly QA.
Provide quality oversight at CMs, acting as the initial point of contact for quality-related issues.
Escalate quality concerns to Lilly QA management as required.
Assist in establishing and revising Quality Agreements with affiliates and customers.
Coordinate and perform QA responsibilities for API shipments.
Participate in regulatory inspection preparations and provide on-site support during manufacturing events and inspections.
Batch Review & Documentation
Participate in Technical Review Boards and evaluate/disposition API batches as needed.
Ensure completion and accuracy of Certificates of Testing, Certificates of Environmental Monitoring, deviations, change controls, and batch documentation prior to batch release.
Maintain holistic oversight of key manufacturing activities impacting product quality.
Assess deviation investigations and changes to ensure proper documentation and traceability.
Ensure processes remain in an appropriate state of control.
Continuous Improvement & Project Participation
Maintain awareness of external regulatory agency findings relevant to product quality.
Review and approve documents including procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
Participate in Annual Product Reviews (APRs) and projects to improve productivity.
Contribute to Joint Process Teams (JPT) and Post Launch Optimization Teams (PLOT).
Qualifications & Experience
Education
Bachelor of Science in Pharmacy, Chemistry, Biological Sciences, or related Life Sciences (required)
Master of Science (preferred)
Experience
Minimum 10 years in a Quality Assurance role within “big pharma” as Market Authorization Holder for non-generic products
Minimum 5 years of GMP manufacturing floor QA experience in API production
Demonstrated knowledge of ICH and EMA regulations
Experience in internal, customer, and regulatory inspections
Experience in process validation and technical transfer
Skills & Competencies
Strong written and verbal communication skills in English
Coaching and mentoring capabilities
Root cause analysis and application of statistical methods
Attention to detail and organizational skills
Ability to influence diverse groups and manage stakeholder relationships
Proficiency in computer system applications
Excellent interpersonal and networking skills
Other Requirements
Required onsite 2–3 days per week and support 24-hour/day operations
Travel up to 25%, primarily to Vizag
Completion of required API EM Quality Assurance training
Equal Opportunity & Accessibility
Lilly is committed to fostering an inclusive workforce and provides accommodations for individuals with disabilities. To request accommodations during the application process, please complete the workplace accommodation form.
Lilly is an equal opportunity employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity/expression, national origin, veteran status, disability, or any other legally protected status.
#WeAreLilly
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