Quality Assurance Associate
Quality Assurance Associate
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. jid781d2b5a jit0418a jiy26a