Subject Matter Expert (m/w/d) in der Qualitätskontrolle Validierung

KVP Pharma+Vet. Produkte GmbH; Kiel; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

MTV salary

13th salary

€40 holiday pay per day

Pension scheme

37.5h week

30 days vacation

Hansefit membership

Job ticket subsidy

Free parking

Zusammenfassung

KVP Pharma+Vet. Produkte GmbH in Kiel, Germany seeks a Subject Matter Expert (m/f/d) in Quality Control Validation to lead method establishment for active ingredients and finished products.

You will coordinate QC projects and ensure regulatory compliance across international teams. Requirements include a university degree in pharmacy or chemistry, 3+ years GMP experience with statistics, and fluent German with proficient English.

Qualifikationen

• University degree in pharmacy or chemistry.
• 3+ years GMP experience with statistics and data evaluation.
• Fluent German and proficient English.
• Knowledge of analytical techniques (HPLC, GC) and method establishment.

Aufgaben

• Establish and optimize new analytical test methods for active ingredients and finished products.
• Plan, validate, and evaluate analytical method verifications for new product projects.
• Coordinate QC project activities and liaise with the project team; ensure milestones.
• Ensure regulatory compliance and prepare audit documentation.

Kenntnisse

GMP experience

Statistical methods

Data evaluation

German fluency

English proficiency

Ausbildung

Pharmacy degree

Chemistry degree

Tools

HPLC

GC

Jobbeschreibung

Your Role: Subject Matter Expert (m/f/d) in Quality Control Validation

The position is initially limited to 2 years.

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.

What You Need to Succeed (minimum qualifications):

• 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.

What will give you a competitive edge (preferred qualifications):

• 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.

Additional Information:

• Location: Kiel, Germany - On-site Work Environment.
• Travel: 0%.
• Position: Limited contract of 2 years.

WHAT WE OFFER YOU

• 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.