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Job Description
Simtra BioPharma Solutions, a leading contract development and manufacturing organization with over 65 years of experience, is seeking an Expert (m/w/d) Product Compliance to join their team in Halle/Westfalen, Germany. This role is crucial in ensuring the quality control analysis of commercial customer products, active pharmaceutical ingredients, and raw materials, adhering to pharmacopoeia guidelines, regulatory requirements, and customer specifications.
The Expert will be responsible for creating and optimizing testing protocols, test methods, and specifications for analyzing semi-finished goods, active ingredients, excipients, and packaging materials. He/She will also evaluate and verify compliance with cGMP guidelines during product and raw material analysis. Simtra believes the role involves addressing analytical issues, handling complaints, change controls, deviations, OOT/OOS events, and unusual findings.
Furthermore, the role entails planning, supervising, and evaluating ICH-compliant stability studies, compatibility studies, and special studies, along with managing all lifecycle management activities for approved products and generating documents for cleaning validation.
Simtra mentiones the role will involve:- Creating and optimizing testing protocols, test methods, and specifications
- Evaluating cGMP compliance
- Addressing analytical issues
- Handling complaints, change controls, deviations, OOT/OOS events
- Managing lifecycle activities
- A degree in Pharmacy, Chemistry, or Biotechnology, ideally with a doctorate
- Experience in a GMP-regulated environment and quality control is desirable
- Strong pharmaceutical, analytical, and regulatory knowledge (GMP)
- Project management skills
- Organizational, problem-solving, and assertiveness skills
- Excellent German and English skills
- Attractive Compensation
- 30 days of holiday
- Subsidized canteen
- Job-Rad Leasing
- Good transport connection
- Free parking spaces with e-charging stations
- Free company sport activities
