DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland)

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.

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 be also 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 of 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 trouble shooting 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.
  • Serving as a liaison between the CM and JPT.
  • Ensuring 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