October 21, 2024

Lilly

OTHER

Principal Associate QA API External Mfg Person In Plant (PIP)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Overview:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world.
The PIP role provides leadership and functional-area expertise at the designated Contract Manufacturer site, in conjunction with API EM contract manufacturing personnel working at Lilly affiliate sites (e.g., Indianapolis, Kinsale, Puerto Rico) to achieve the reliable and compliant manufacture of API drug substance that meets predetermined global quality standards.
A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturer. The position requires knowledge of c GMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Overall, the PIP role is responsible for:

Day to Day production support
Monitoring ongoing production support (e.g., production meeting attendance)
Periodic housekeeping / fit & finish walk-throughs with area management.
Tracking of resolution of identified issues
Practice vs procedure walk throughs with management
Serving as an active member of the Lilly process and applicable PLOTs
Conformation of CAPA implementation
Effective management of internal and external stakeholders
Adhering to Lilly’s Business, Quality, and Financial Systems

Location:
This PIP role is located in Incheon, South Korea. The candidate must be within commuting distance, as they are expected to be on site at the contract manufacturer 3-days per week.
QA-Specific Responsibilities:
The QA Associate is responsible for ensuring all batches meet specifications, are manufactured in accordance with the validated process, and are compliant to c GMPs and regulatory commitments.
Detailed responsibilities include…

Providing quality oversight of CMs including being the initial point of contact for all quality-related issues.
Escalating quality issues at CMs to Lilly QA management.
Assisting in the establishment and revisions of Quality Agreements with affiliates and customers.
Providing quality oversight of Lilly/APIEM Quality Plans.
Coordinating and perform QA responsibilities of API shipments.
Participating in regulatory inspection preparations with CMs.
Providing on-site support during manufacturing events and inspections.
Participating on the Technical Review Board.
Evaluating and dispositioning of API batches, if required.
Ensuring that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
Providing quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
Assessing the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
Ensuring all processes are in an appropriate state of control.
Maintaining awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
Reviewing and approving documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
Participating in APR activities.
Participating in projects to improve productivity.

Basic Requirements:

BS in STEM discipline (Chemistry/Biochemistry strongly preferred)
GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering
Demonstrated ability to function in a cross-functional team environment and to provide technical leadership
Demonstrated ability to manage and prioritize competing priorities
Strong written and verbal communications skills with various audiences
Ability to influence diverse groups and manage relationships
Willingness to relocate to contract manufacturing site or an estimated 3-year assignment before returning to designated Lilly site

Additional Preferences:

Experience in quality support for Drug Substance manufacturing activities
Thorough technical understanding of quality systems and regulatory requirements
Knowledge of pharmaceutical manufacturing operations
Demonstrated coaching and mentoring skills
Experience in root cause analysis
Demonstrated application of statistical skills
Proficiency with computer system applications

Additional Information:

Must complete required training for API EM Quality Assurance
Some international travel (<25%) is required primarily to Indianapolis, Indiana

Some off-shift work (night/weekend) may be required to support 24/7 operations

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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