Associate QA DPEM

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.

MAIN RESPONSIBILITIES

To act as the primary Lilly (DPEM) quality contact for the following:

Provide quality support for existing products / existing External Manufacturers (EM)

The roles and responsibilities are broad and varied and may include

Ensure EMs are following appropriate quality systems as part of routine operations e.g. change control and deviation management. Use regular visits, JPT and other communications to help monitor/assess performance.

Build and maintain good communications with EMs and awareness of issues/progress, including reporting back to DPEM Management. Also, respond to requests for data and information.

Flexible to visits EMs if needed.

Quality systems execution :

Perform Lilly batch dispositions (if required) - approve and provide appropriate documentation.

Responsible for the evaluation and management of deviations through the appropriate DPEM/local affiliate and External Manufacturer quality systems, including evaluation/management of deviations for regulatory impact.

Responsible for the evaluation and management of change controls through the appropriate DPEM /local affiliate and External Manufacturer quality systems, including evaluation/management of change controls for regulatory impact.

Investigate and monitor product quality complaints, in conjunction with Technical Services & Manufacturing Science (TSMS).

Provide guidance to EMs on resolution of technical/quality issues, in conjunction with TSMS.

Support Laboratory re-accreditations in conjunction with QC Subject matter experts.

Participate in the development of Annual Product Reviews (APRs) and Periodic Quality Evaluations (PQEs), in conjunction with (TSMS).

Determine the appropriate stability program, manage it to plan and perform periodic evaluation of the data for products manufactured at EMs, and compare to those made at other sites.

Support Direct source re-accreditations with material management team.

Review, revise and maintain Product Specification Data Sheets (PSDSs), material specifications and Quality Agreements (QAs) or maintain oversight if these are the responsibility of another Lilly site.

Participate in the development of Master Batch Records, Packaging Orders, Process Validation Protocols and Reports in conjunction with TSMS and review any updates.

Continuously identify areas for quality improvements in for example buildings, premises, personnel, training, procedures. Manage improvements through the GMP Plan process, supporting/leading EM through the development and preparation of the Plan. Ensure EM completes actions in a timely manner.

Ensure EM is aware of any changes in quality and/or technical requirements and arrange training where appropriate in conjunction with GQAAC/TSMS.

Responsible for corrective action tracking.

Build and maintain good communications with local Lilly affiliates. Also respond to requests for data and information.

Participate in EM performance reviews i.e. metrics, supply management.

Participate in or lead Joint Process Team(s) and/or Alliance Management as required

Participate in or lead After Action Reviews as requested, and feedback to the DPEM Lead Team

Follow-up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the EM is taking appropriate action in the due time.

General

Review, revise and maintain DPEM Standard Operating Procedures (SOPs).

Co-operate with GQAAC in the preparation of Lilly standards and implement at EMs.

Provide input for monthly reports and metrics.

Ensure that Quality Backlog is appropriately managed and issues escalated as necessary.

REQUIRED QUALIFICATIONS/CHARACTERISTICS

Graduate in Chemistry, Pharmacy, or other similar technical background.

It will be considered positively any further experience in technical and quality functions within a manufacturing plant (Assembly device, dry products and packaging process).

Appreciation of cultural diversity.

Flexibility to travel if needed

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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R-61439