Quality Assurance Expert
2 weeks ago
About the Role
The Senior QA Professional will be responsible for ensuring the highest quality in validating and qualification of existing and new equipment. This includes setting direction regarding validation and qualification activities and documentation, reviewing and approving Science and Risk based Validation documentation, performing oversight of both equipment suppliers and on-site, and ensuring compliance with current GMP rules and guidelines to maintain product quality.
This role involves close collaboration with production colleagues and stakeholders to achieve project goals. The ideal candidate will have excellent skills in collaborating with stakeholders from different cultures and organisational levels, thrive in a dynamic environment where cooperation with many different stakeholders is crucial, and work systematically, logically, and proactively.
Responsibilities:
- Setting direction regarding validation and qualification activities and documentation.
- Reviewing and approving Science and Risk based Validation documentation.
- Performing oversight of both equipment suppliers and on-site.
- Ensuring compliance with current GMP rules and guidelines to maintain product quality.
About the Department
PS AM QA KA is responsible for the Aseptic Manufacturing facility in Kalundborg, which produces haemophilia and growth hormone products, with more in the pipeline. The team ensures compliance with the ever-evolving complex requirements and regulations in the aseptic guidelines.
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