QA Representative Dry External Manufacturing

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. 

About Lilly

Manufacturing & Quality Technical Hub, Hyderabad

Job Description

Role Overview and Key Responsibilities

The Dry Product External Manufacturing QA Representative provides support to all quality activities at Contract Manufacturing Organizations (CMs) involved with the manufacturing and packaging of solid oral dosage forms (e.g. tablets and capsules). The QA Representative is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process, and are compliant with cGMPs and regulatory commitments. The role serves as a liaison between CMs and Lilly and is the initial point of contact for all quality-related issues at the assigned CM.

Key Objectives/Deliverables

• Serve as liaison between CMs and Lilly; provide quality oversight of CMs as 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; ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/Dry-EM Quality Plans.
• Coordinate and perform QA responsibilities of Dry Product shipments.
• Participate in regulatory inspection preparations with CMs; provide on-site support during inspections.
• Evaluate and disposition Dry and Packaging Product batches as required.
• Ensure documented checks have been completed for Certificates of Testing, Certificates of Environmental Monitoring (where applicable), and deviations, changes, and batch documentation prior to batch release.
• Provide quality support of Dry Product manufacturing with focus on holistic review of key activities: deviations, change controls, and countermeasures.
• Review and approve documents including procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, process validation, cleaning validation and computerized system validations.
• Participate in Annual Product Review activities, Joint Process (JPT) teams, and Post Launch Optimization (PLOT) Teams.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.

Basic Requirements

• Bachelors degree (BS) in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
• At least 8 years of experience in GMP manufacturing with experience in Dry product and finished product manufacturing, QC, QA, or Engineering.
• Advance to proficiency English level.
• Thorough technical understanding of quality systems and regulatory requirements.
• Knowledge of pharmaceutical manufacturing operations.
• Strong written and verbal communication skills; strong attention to detail.
• Ability to organize and prioritize multiple tasks; ability to influence diverse groups and manage relationships.

Additional Preferences

• Experience in manufacturing floor oversight of solid oral dosage form manufacturing including an understanding of key unit operations (e.g. blending, granulation, compression, coating, and encapsulation).
• Experience in equipment qualification, system validation, and process validation.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis and demonstrated application of statistical skills.
• Proficiency with computer system applications (e.g. SAP, TrackWise, and Veeva QMS).
• Excellent interpersonal and networking skills.

Other Information

• Must complete required training for Dry Product EM Quality Assurance.
• Must be able to support 24-hour/day operations when required.
• Travel is possible, up to 30%.

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.