Subject Matter Expert (m/w/d) in der Qualitätskontrolle Validierung
Indexed description
This role provides technical leadership in the establishment, optimization, and scientific validation of complex analytical test methods for new product projects. You will also coordinate quality control project activities and ensure strict regulatory compliance while fostering international exchange to meet key milestones.
Your Responsibilities:
- Method Establishment & Expertise: Technical responsibility for the establishment of new test methods (active ingredients and finished products) as well as their optimization and troubleshooting in complex analytical issues.
- Validation & Verification: Scientific planning (including the application of statistical methods), implementation and evaluation of validations and verifications of analytical methods in the context of new product projects.
- Technical project management: Coordination of project-related activities within quality control and acting as a technical contact person vis-à-vis the higher-level project team. Ensuring close coordination on project milestones and promoting international knowledge exchange.
- Regulatory Compliance & Documentation: Ensuring regulatory compliance within analytical transfer projects as well as drafting and approving audit requirements
- Education: Completed university degree in pharmacy or chemistry.
- 3+ years professional experience in the GMP environment as well as in-depth knowledge of statistical methods and data evaluation
- Fluent German and proficient English language skills required
- Knowledge of common analytical techniques in chemical laboratories (especially HPLC and GC) as well as experience in method establishment
- High level of commitment, flexibility for new challenges and reliability
- Strong interest in building deep technical expertise and acting as a scientific anchor point within the department
- Ability to document complex issues precisely and scientifically sound and to present them to different audiences in a way that is appropriate for the target group.
- Ability to make data-driven decisions and to apply complex statistical evaluations for method characterization.
- Location: Kiel, Germany - On-site Work Environment
- Travel: 0%
- Position: Limited contract of 2 years.
- Attractive salary according to the chemical tariff (MTV): 13th monthly salary (Christmas bonus) and 40 € holiday pay per day. Plus: employer-financed pension scheme.
- Work-life balance: 37.5-hour week and 30 days of vacation. On top of that, there is the"future amount" (up to 5 extra days off or cash), overtime? Are recorded and compensated for by free time.
- Well-being: Hansefit membership, annualevents (our employee party is legendary!) and preventive care offers directly on site.
- Convenient commute: Subsidy for the job ticket or bike leasing and free parking.
- Benefits: Employee share purchase program and corporate benefits platform.
Elanco is an EEO/Affirmative Action Employer and 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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
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