Quality Assurance Specialist for Aseptic Manufacturing
16 hours ago
About the Role
We are seeking a highly skilled Quality Assurance Specialist to join our team in Aseptic Manufacturing. In this role, you will be responsible for ensuring products of the highest quality are released to the market.
Key Responsibilities
- Safeguard that analytical results are released in full compliance with current practices and guidelines from authorities.
- Review and approve various types of GMP documentation related to analytical methods and laboratory equipment.
- Oversee analyses performed such as HPLC, Bio- and Immunoassay, and general pharmacopeia methods including microbiology.
- Support the development and validation of analytical and microbial methods for new products entering our product pipeline, both in-house and at Contract Manufacturing Organizations.
- Support and oversee quality activities at our QC laboratories.
Qualifications and Skills
- At least 1 year of experience in the pharmaceutical industry, from e.g. QA, QC, or production.
- A master's degree within pharmacy, chemistry, microbiology, engineering, or similar.
- IT knowledge and competencies are considered an advantage.
- Fluency in English is required.
About the Department
You will join a team in a highly dynamic, newly established department with many interfaces and stakeholders around the organization.
The department consists of four teams who support and oversee QC laboratories and analytical methods, support functions to production and product life cycle, support projects and IT, and are highly involved in the core of quality processes and authority inspections.
The department has a high level of self-governance, and the working relations are informal. We value good humor and an open and honest culture.
Working at Novo Nordisk A/S
We always strive for excellence and continuously develop our expertise to stay ahead - both as a company and as individuals. We believe that innovation and creativity thrive in a healthy and engaging working environment.
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