QA Representative - API EM

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Position Brand Description:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The PIP (person in plant) API EM Quality Assurance Principal Associate will provide support to all quality activities within a dynamic external manufacturing environment. The PIP position is based in Hyderabad, India with travel as required to Visag. The candidate must be within commute distance.
The QA Associate’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. The QA Associate will need to interact daily with a wide variety of people, primarily external partners team members and site management.
Key Objectives/Deliverables:
Serve as a liaison between CMs and Lilly.
Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
Escalate quality issues at CMs to Lilly QA management.
Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
Provide quality oversight of Lilly/APIEM Quality Plans
Coordinate and perform QA responsibilities of API shipments.
Participate in regulatory inspection preparations with CMs.
Provide on-site support during manufacturing events and inspections.
Participate on the Technical Review Board
Evaluate and disposition API batches, if required.
Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
Ensure all processes are in an appropriate state of control.
Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
Participate in APR activities.
Participate in projects to improve productivity.
Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Basic Requirements:
BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
Previous GMP manufacturing experience in API manufacturing in a Quality Assurance role (minimum 5 years of GMP QA on the floor support)
Minimum 10 years of experience in a Quality Assurance role in “big pharma” as the Market Authorization Holder for non-generic products.
Demonstrated foundational knowledge of ICH and EMA regulations.
Experience participating in internal, customer, and regulatory inspections
Process Validation and Technical Transfer experience
Fluent in English
Additional Preferences:
Demonstrated coaching and mentoring skills.
Experience in root cause analysis.
Demonstrated application of statistical skills.
Demonstrated strong written and verbal communications skills.
Strong attention to detail.
Proficiency with computer system applications.
Excellent interpersonal skills and networking skills.
Ability to organize and prioritize multiple tasks.
Ability to influence diverse groups and manage relationships.
Education Requirements:
BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
Master of Science preferred
Other Information:
Must complete required training for API EM Quality Assurance.
No certifications required.
Required onsite 2-3 days a week and must be able to support 24 hour/day operations.
Some travel (<25%) is required primarily to Vizag
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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