DPEM QA Person in Plant-Drug product external manufacturing

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $140,800.

Responsibilities

This role is responsible for providing daily quality oversight at the Contract Manufacturers (CM) site. This role is located in person on site at the CM site the majority of the time and will help set up the processes for device assembly and packaging at the CM, supporting the Technical transfer until process validation. Additional responsibilities include providing assistance and guidance during routine manufacturing to issues such as deviation investigations, change control proposals, procedure/master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities.

QA Person in Plant may also be responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information. They also ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

Important note: Location is at the CM manufacturing site – Dublin, Ireland.

Key Objectives/Deliverables:

- QA Person in Plant should understand the process and equipment for their product scope, including:

- Understanding the science behind the process and equipment so that compliance-based decisions ensure ongoing effective and efficient processes.

- Knowing how upstream/downstream processing is affected by their process steps.

- Knowing the Operational Control Strategy (OCS) and failure modes of the process.

- Knowing the historical deviations/gaps, trends, and audit history of the process.

- QA Person in Plant should provide support to the CM daily operations by:

- Help the CM develop the quality system and process for device assembly and packaging.

- Levelling, reviewing, and approving event investigations and changes.

- Ensuring implementation and effectiveness of corrective and preventative actions.

- Reviewing that practice matches procedure.

- Ensuring CM's quality systems are compliant with applicable GMPs, Lilly quality standards, and any additional local market requirement.

- Contribute to Quality culture efforts at both DPEM and CM.

- Spend time in all unit operations, including the laboratory.

- Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult).

- Support onsite resolution of product-related issues.

- Ensure compliance to data integrity (i.e. perform audit trail reviews).

- Perform troubleshooting for in-process issues and escalate as needed.

- Review and provide approval for CM procedure changes.

- Write protocols for non-routine testing or validation with appropriate guidance.

- Participate on Joint Process Teams (JPT).

- Review, enter, or SPV analytical data and escalate as needed.

- Ensure batches are identified and appropriately sampled for annual stability requirements.

- Provide on-site support for GQAAC audits and Regulatory inspections.

- Review and approve complaint investigations.

- Consult on Master batch record updates; provide input based on observations and interactions on the floor.

- Metrics tracking.

- Assist in gathering data to complete the CMs Site Compliance Reports (SCR); provide review as needed.

- Perform internal notification of quality issues where needed.

- Serve as a liaison between the CM and JPT.

- Ensure that materials and products manufactured at CMs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market.

- Participate in CM performance reviews (Ex IOPs, supply management, etc.).

- Track and monitor quality metrics for trends at the CMs.

- Support batch release activities by:

- Complete batch record review reporting any issues.

- Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.

- Originate and investigate deviations associated with batch records discrepancies, stability issues, atypical and out of trend results for either chemical, micro or device test (if applicable).

- Work with Lilly support groups to resolve product-related issues (such as IDM, PDS, GQAAC, Parenteral network).

- Create Certificates of Analysis or other similar documentation for internal and external customers as needed.

- Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product).

- Provide support for Notification to Management data gathering.

- Provide input for metrics reports to management.

- Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers.

Relationships:

- Develop and maintain strong working relationships with CM, primary DPEM contacts, QA/QC personnel, and shop floor personnel at the CM as well as with DPEM JPT members.

- Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations.
- Assist QA Primary and secondary loop role with providing potential topics for GQAAC audit of the CM.
- Assist CMs on the preparation of any audit from Lilly (GQAAC) or any external agency inspection that impact Lilly products.
- Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the CMs is taking appropriate actions in due time.

Continuous Improvement:

- Support continuous improvement initiatives at the CM (i.e. identify vulnerabilities and inefficiencies of the process and promote improvement projects).
- Ensure quality improvements are managed through the GMP plan process. Ensure evidence of completion and completes in a timely manner.

Basic Qualifications

- Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science or equivalent experience.

- Minimum 3-5 years of experience supporting quality and/or technical functions within Device Assembly/packaging operation.

Additional Skills/ Preferences

- Regulatory related experience.
- Established technical, quality, and internal networks.
- Experience with Lilly systems (SAP, Trackwise, Q docs, etc.).
- Previous experience supporting batch release for parenteral and/or packaging products may be preferred.
- Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
- Demonstrated ability to work independently.
- A thorough understanding of cGMPs and Global Quality Standards.
- Strong written and communication skills, especially attention to detail in written procedures and protocol development.
- High learning agility.
- Strong leadership, interpersonal, and teamwork skills, able to work effectively in a cross-functional team environment.
- Ability to organize, prioritize, multi-task, and influence others.
- Ability to influence CM and guide them through Lilly principles.
- Strong decision-making and problem-solving skills.
- Willingness to learn new technologies.
- Capability to work in a virtual and complex environment.
- Willingness to travel.
- Appreciation for cultural diversity.

Additional Information

- Shift is days, but schedule flexibility and off hours may be necessary to support operations.
- Location is at the CM manufacturing site – Dublin, Ireland.
- Some travel (
- This role requires on-site presence at the contract manufacturer (located in Dublin, Ireland), a minimum of 3 days per week. In order to fulfill this on-site commitment, employees are expected to travel (by car) 3+ times/week to the site.

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 (here) 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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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