Qualified Person; QP m​/w​/d

Position: Qualified Person (QP) - (m/w/d)
Location: Germany

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."
** Join our Lilly team in Alzey and start as soon as possible as:
**** Qualified Person (QP) - (m/w/d)
** Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for an experienced Qualified Person (QP) to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The QP is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility. These provisions include ensuring that the batch has been produced according to appropriate standards and has successfully passed all required tests.
** Certification and Release of Finished Batches
*** Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
* Confirms batches of products intended for clinical trials.
* Approves batch certificates.
* In case of non-compliance detected at their level, decides on necessary actions.
* Ensures periodic monitoring of the quality review activity for semi-finished
** Quality and Regulatory Monitoring
*** Continuously updates knowledge by staying informed of technical, regulatory, and scientific developments.
* May consult regulatory dossiers for the marketing authorization of products they confirm, certify, and release.
* May consult quality contracts necessary for the confirmation, certification, and release of product batches, and participates in their updates.
* Ensures documented oversight of imported products and active substances.
** Quality Assurance
*** Performs analysis of corporate standards and participates in their implementation on site.
* Participates in the implementation of new regulations.
* Acts as approver and/or reviewer of procedural documents related to their activity.
* Approves regulatory specifications of manufactured products in the LIMS system.
* Approves in SAP the list of countries registered for finished product codes.
* Acts as reviewer for the Annual Product Review (APR) of the Alzey site, ensuring the quality of the analysis and conclusions.
* Conducts impact analyses in the change management system related to their area of expertise.
* Verifies the application of the quality system in and outside the quality department (especially through audits).
* Responsible for the annual stability strategy on site.
* Responsible for the annual visual inspection strategy on site.
* Approves stability protocols.
* Represents Quality Assurance at the monthly CCRC Committee.
* Communicates with subsidiaries/other manufacturing sites regarding the decision to quarantine already shipped batches.
* Prepares ANIRs (Additional New Information Reports) as part of Annual Reports (e.g., US, Mexico, etc.).
** Technical Support
*** May be responsible for implementing changes related to their activity.
* Conducts impact analyses of change controls…