Lilly is looking for a Dry EM Quality Assurance Representative to provide quality oversight and support for contract manufacturing organizations (CMs) involved in the manufacturing of bulk dry products (tablets/capsules) and packaging. The role is crucial for ensuring that all manufactured batches meet specifications, adhere to validated processes, and comply with cGMPs and regulatory commitments, thereby maintaining the quality and integrity of Lilly's products.
Requirements
- 3+ years previous GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering.
- Experience in quality support for Quality Control activities
- Thorough technical understanding of quality systems and regulatory requirements.
- Knowledge of pharmaceutical manufacturing operations.
- Experience in root cause analysis.
- Demonstrated application of statistical skills.
- Proficiency with computer system applications.
Responsibilities
- 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.
- 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 Bulk/finished product shipments.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
- Evaluate and disposition batches of bulk and finished product, if required.
Other
- Serve as a liaison between CMs and Lilly.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Must complete required training for Dry-EM Quality Assurance.
- Must be able to support 24 hour/day operations.
- Willingness to travel, expected 30% travelling.
