QA Representative – Dry External Manufacturing

Overview

Provide quality oversight for contract manufacturing organizations involved in manufacturing and packaging solid oral dosage forms such as tablets and capsules. Serve as Lilly's initial point of contact for quality-related issues at assigned contract manufacturers and help ensure batches meet specifications, follow validated processes, and comply with cGMPs and regulatory commitments.

What you'll do

• Serve as liaison between contract manufacturers and Lilly and provide quality oversight as the initial point of contact for quality-related issues.
• Escalate quality issues at contract manufacturers to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents.
• Provide quality oversight of Lilly/Dry-EM Quality Plans.
• Coordinate and perform QA responsibilities for Dry Product shipments.
• Participate in regulatory inspection preparations with contract manufacturers and provide on-site support during inspections.
• Evaluate and disposition Dry and Packaging Product batches as required.
• Complete documented checks for Certificates of Testing, Certificates of Environmental Monitoring where applicable, deviations, changes, and batch documentation before batch release.
• Provide quality support for Dry Product manufacturing through holistic review of deviations, change controls, and countermeasures.
• Review and approve 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 teams, and Post Launch Optimization teams.
• Maintain awareness of external regulatory agency findings that reference product quality individually or collectively.

What you'll need

• Bachelor's 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.
• Advanced 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.

Nice to have

• Experience in manufacturing floor oversight of solid oral dosage form manufacturing, including understanding of key unit operations such as 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 such as SAP, TrackWise, and Veeva QMS.
• Excellent interpersonal and networking skills.

Details

• Location: Hyderabad, India.
• 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%.