Quality Assurance Associate
Job description:
Responsibilities include:
* 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.
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