QA for QC – 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. 

Company Overview Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 150 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Manufacturing and Quality Technical Hub Hyderabad Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub in Hyderabad, India. This hub will oversee the significant investment in contract manufacturing and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of manufacturing operations, quality assurance, quality control, supply chain, technical services, and engineering to build a cutting-edge scientific organization supporting the exciting dry products external manufacturing portfolio of Lilly.

Job Description Role Overview and Key Responsibilities: The Dry Product External Manufacturing QA Representative (QA for QC) provides quality assurance oversight of Contract Manufacturing Organizations (CM’s) laboratory operations, ensuring that analytical testing, data integrity practices, laboratory systems, and quality controls meet Lilly standards, cGMP requirements, and applicable regulatory expectations for CM’s 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 testing meet specifications and analysed in accordance with validated practices. The role serves as a liaison between CMs laboratory operations and Lilly and is the initial point of contact for all quality-related laboratory issues at the assigned CM.

Key Objectives/Deliverables: Serve as liaison between CMs and Lilly; provide quality oversight of CMs laboratory operations and acts as the initial point of contact for all laboratory related issues. Escalate quality issues at CMs to Lilly QA/QC management. Coordinate and perform QA responsibilities of lab sample shipments. Participate in regulatory inspection preparations with CMs; provide on-site support during inspections. Conduct routine review of CM laboratory practices through data integrity assessments, audit trail reviews, analytical instrument record review, and raw data traceability. Perform review and approval of documents including analytical testing methods, SOPs, method transfer and validation protocols, change control proposals, and analytical equipment qualifications. Oversee CM laboratory investigations (e.g. Out of Specification deviations) and CAPA management, providing QA review and approval of root cause analyses and effectiveness checks for laboratory-originated events. Provide QA oversight of the dry product stability program, including review of stability protocols, data, and storage condition compliance at CM sites. 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: Bachelor's degree (BS) in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences. At least 8 years of GMP experience, with experience in pharmaceutical laboratory quality assurance, quality control, or laboratory operations in a dry product or solid oral dosage form environment. Advance to proficiency English level. Thorough understanding of laboratory quality systems including OOS/OOT investigation requirements, method validation, method transfer, specification management, and regulatory requirements. 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: Knowledge of analytical techniques common to solid oral dosage forms (e.g. HPLC, dissolution, particle size analysis, moisture analysis such as LOD and Karl Fisher, and physical characteristics testing such as hardness, friability, and disintegration. Knowledge regarding Specification and Materials/Supplier Management. Knowledge of pharmacopeia requirements (e.g. USP, Ph. Eur., and /JP). Experience reviewing and assessing laboratory data integrity controls, including audit trail review, system access controls, and raw vs. processed data traceability. Demonstrated knowledge regarding product stability and program oversight. Demonstrated coaching and mentoring skills. Proficiency with computer system applications (e.g. Darwin/LIMS, Empower, GPCMS, SAP, Trackwise, and Veeva QMS). Knowledge of pharmaceutical manufacturing operations. 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.

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