Description

Job description:

Requirements:

• Provide support and consultation in the areas of aseptic manufacturing and microbiological laboratories (without performing hands-on tasks in manufacturing or the laboratory)
• Verifying and ensuring compliance with GMP requirements in production
• Monitoring, verifying, and documenting work steps; reviewing processes in aseptic production
• Assisting with the training and (re)qualification of aseptic production staff
• Providing support to production in the event of issues throughout the entire manufacturing process regarding compliance and risk assessment (on-call duty)
• Handling deviations in the area of aseptic filling:

- Conducting initial assessments
- Providing support in defining the investigation strategy, including evaluating technical assessments as part of the investigation.
- Supporting the operations team in investigating deviations, including defining appropriate corrective and preventive actions (CAPAs) to prevent the recurrence of a similar deviation.
- Reviewing investigation reports in German and English and evaluating them with regard to compliance and risk assessment.

• Collaboration in preparing for deviations during internal and external inspections.
• Support in reviewing regulatory documents

Competences:

• A degree in the natural sciences (Bachelor's, Master's, or PhD) or a comparable qualification.
• GMP experience or knowledge of the pharmaceutical industry is advantageous.
• An analytical mindset and the ability to quickly grasp logical relationships and present them in an easily understandable, structured manner.
• A good understanding of the logical structure of texts and reports and the ability to critically evaluate them.
• Team-oriented thinking, strong communication skills, assertiveness, and the ability to engage with people at all levels of the organization.
• Ability to quickly shift focus between managing multiple projects and adapt to changing circumstances.
• A high degree of independence and initiative.
• Native German speaker with very good written and spoken English skills.