Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. The Dry Product External Manufacturing Quality role provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
Requirements
- Experience in quality support for Quality Control activities
- Experience on equipment qualification, system validation and process validation.
- 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.
- 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/DryEM Quality Plans
- Coordinate and perform QA responsibilities of Dry Product shipments.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
Other
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- At least 3 years experience on GMP manufacturing and/or experience in Dry product and finished product manufacturing, QC, QA or Engineering.
- Demonstrated coaching and mentoring skills.
- Demonstrated strong written and verbal communication skills.
- Strong attention to detail.
