Quality Assurance Specialist
Are you passionate about Quality Assurance and do you like to be challenged by an exciting day? Then you may be the Quality Specialist we’re looking for!
Are you passionate about Quality Assurance and do you like to be challenged by an exciting day? Then you may be
the Quality Specialist we’re looking for!
We are EU GMP certified contract laboratory focused on providing chemical analysis and consulting for research, development, and regulatory compliance applications to pharmaceutical companies. Headquartered in Odense, Denmark and dedicated to developing a platform of innovative analytical methods while maintaining the highest level of quality to forge new industry standards. As global sentiment is increasingly focused on quality data, er are determined to improve transparency and access to robust scientific analysis by working hand-in-hand with global pharmaceutical industry stakeholders through analytical testing.
You will be part of our Quality Assurance (QA) team, whose main responsibility is to assure that the company’s Quality Management System adheres to the current GMP legislation. The QA team also supports the Quality Control team while they perform a variety of different analytical methods. Together with your colleagues, you ensure that we keep focus on high quality analysis and robust delivery of results.
Your main tasks will include:
- Developing and continued maintenance of our Quality Management System (QMS)
- Handling and managing risk assessments, change controls, deviations, and CAPAs
- Overseeing quality processes and compliance focused KPIs
- Supporting internal GMP training of employees
- Quality Assurance support on qualification of equipment and validation processes
- Customer Quality Contract review for quality related issues
- Participating and follow-up of customer audits
We need you to
- Be committed, structured and work focused on your tasks
- Enjoy working in close cooperation with the QC Labs’ customers and QC personnel and aiming to deliver top quality results in time
- Thrive working in a GMP environment with high focus on quality
- Be able to manage multiple priorities and meet scheduled milestones
- Hold a master’s degree in pharmacy, biochemistry, biotechnology, chemical engineering, or related fields
- Minimum 5 years GMP experience in Quality Assurance within the pharma industry
- Experience / Understanding of analytical chemistry would be advantageous
- Structured organizational skills and capability of working independently
- Ability to read, write, and speak fluently in English & Danish
5220 Odense SØ