Senior Scientist, Quality Assurance Full-time

Senior Scientist, Quality Assurance

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 Scientist, Quality Assurance, provides daily oversight, assistance, and guidance to the site-based process team supporting one of the following manufacturing areas:

• Equipment Prep and Formulation
• Parenteral Filling and Visual Inspection
• Device Assembly
• Parenteral 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.

Responsibilities:

• 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 support 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.
• Assess 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 protocols, 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.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• 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

Additional Information:

• Primary location is Alzey, Germany
• Ability to travel (approximately 10-20 %)
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role
• Ability to work overtime as required.

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 for further assistance. Lilly 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.

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