Senior Quality Associate, Parenteral (m/w/d)

Eli Lilly and Company; Alzey; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading global healthcare company in Alzey is seeking a Senior Quality Associate to oversee quality assurance in a high-tech production facility. The ideal candidate will have a Bachelor's degree, 5+ years of experience in the pharmaceutical industry, and be fluent in English and German. This role focuses on maintaining GMP compliance and supporting manufacturing operations with guidance on quality matters. Attractive benefits and career development opportunities are offered.

Leistungen

Excellent company pension plan

Attractive salary

Professional development opportunities

Qualifikationen

• Minimum 5 years in the pharmaceutical industry with specific Quality Assurance experience overseeing shopfloor execution.
• Demonstrated understanding of cGMP regulations.
• Previous experience in parenteral manufacturing environments required.

Aufgaben

• Provides guidance on non-conformance investigations and quality issues.
• Ensures regular presence in operational areas to monitor GMP programs.
• Participates in self-led inspections and provides support during regulatory inspections.

Kenntnisse

Quality Assurance

Fluent in English and German

Communication Skills

Root Cause Analysis

Technical Writing

Interpersonal Skills

Ausbildung

Bachelor's degree in a science, engineering, or pharmaceutical-related field

Tools

Manufacturing Execution Systems

Electronic Validation Software (e.g., KNEAT)

Jobbeschreibung

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 Associate, Parenteral (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 Associate, Parenteral provides daily oversight, assistance, and guidance to the site-based process team supporting one of the following manufacturing areas:

• Equipment/ Material Prep and Formulation
• Parenteral Filling and Visual Inspection

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.

What tasks await you?

• 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.

How do you convince us?

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 regulatory compliance.
• Fluent in English and German.
• On‑site presence required.

Additional Requirements:

• Previous experience in parenteral manufacturing environments (equipment/ material prep, formulation, filling, and visual inspection).
• Previous experience with C&Q and Validation oversight including automation and computer systems validation
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as a team
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and ability to maintain quality systems
• Proven ability to work independently or as part of a Team to resolve an issue
• Technical Writing and Communication Skills
• Computer System Quality Assurance (CSQA) experience
• Previous experience with Manufacturing Execution Systems.
• Previous use of KNEAT – or other electronic validation software

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high‑tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross‑functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Corporate Lilly University."
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

Have we piqued your interest? Then please apply online with your complete application documents through our applicant portal. We look forward to your application!

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Lillydoes 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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