QA Representative - API EM

Overview

Serve as the PIP API EM Quality Assurance Principal Associate supporting quality activities in a dynamic external manufacturing environment. Ensure API batches meet specifications, follow validated processes, and comply with cGMPs and regulatory commitments.

What you'll do

• Serve as a liaison between contract manufacturers and Lilly.
• Provide quality oversight of contract manufacturers and act 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.
• Provide quality oversight of Lilly/APIEM Quality Plans.
• Coordinate and perform QA responsibilities for API shipments.
• Participate in regulatory inspection preparations with contract manufacturers.
• Provide on-site support during manufacturing events and inspections.
• Participate on the Technical Review Board.
• Evaluate and disposition API batches, if required.
• Ensure documented checks are completed for Certificates of Testing, Certificates of Environmental Monitoring where applicable, deviations, changes, and batch documentation before batch release.
• Provide quality support for API manufacturing through holistic review of key activities associated with or impacting manufacturing processes, including deviations, change controls, and countermeasures.
• Assess the impact of deviation investigations and changes and ensure appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings that reference product quality individually or collectively.
• Review and approve 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 and Post Launch Optimization Teams.

What you'll need

• 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, including a minimum of 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.
• Fluency in English.
• Completion of required training for API EM Quality Assurance.
• No certifications are required.

Nice to have

• Master of Science.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communication skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.

Details

• Based in Hyderabad, India, with travel as required to Visag.
• The candidate must be within commute distance.
• Required onsite 2–3 days a week.
• Must be able to support 24-hour-per-day operations.
• Some travel is required.