Senior Quality Scientist, Device Assembly and Packaging; m​/w​/d

Position: Senior Quality Scientist, Device Assembly and Packaging (m/w/d)
Location: Germany

Senior Quality Scientist, Device Assembly and Packaging (m/w/d) page is loaded## Senior Quality Scientist, Device Assembly and Packaging (m/w/d) locations:
Germany, Alzeytime type:
Full time posted on:
Posted Todayjob requisition :
R-100217

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:
**** Senior Quality Scientist, Device Assembly and Packaging** **(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 experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Quality Scientist, DAP provides daily oversight, assistance, and guidance to the site-based process team supporting one of the following manufacturing areas:
* Device Assembly
* Packaging The QA representative supporting the process team provides guidance on issues such as non-conformance investigations, change controls, procedures, validations, batch disposition, and commissioning and qualification activities.  The individual in this role advises and provides support for other floor support QA Representatives.  This position is essential for maintaining GMP compliance and ensuring inspection readiness.
* Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
* Leads, mentors, and coaches operations and supports personnel on quality matters.
* Ensures regular presence in operational areas to monitor GMP programs and quality systems.
* Serves as the Quality point of contact on the local process team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence.
* Assesses and triages deviations that occur within the local process team.
* Works with Lilly support groups and external partners to resolve or provide advice on product related issues.
* Participates in self-led inspections and provides support during regulatory inspections.
* Initiates, reviews, and approves documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation documents, change controls, engineering documents)
* Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.
* Approves commissioning, qualification, and validation documents for computer systems and equipment to ensure compliance with quality standards.
* Networks with Global Parenteral Network sites to benchmark and replicate best practices.
** Basic Requirements:
*** Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
* Minimum 5 years in the pharmaceutical industry with specific Quality Assurance experience overseeing shopfloor execution.
* Demonstrated understanding of cGMP regulations:
Knowledge of cGMP practices including good documentation practices, data integrity and…