The QA Drug Substance Process team consists of 8 highly skilled specialists supporting drug substance manufacturing and as such you will be the natural back up and sparring partner to your colleagues and you will be reporting to the QA Senior Manager for the Process team. Together, we shape the QA mindset for the future and we like to have fun while doing so.
In this role you will assess drug substance quality through batch record review which is performed on the floor during manufacturing and you will be part of assessing changes related to the manufacturing process to ensure campaign readiness and life cycle management. You will have a close collaboration with different stakeholders incl. manufacturing documentation, Manufacturing Sciences, Quality Control and Automation. You will maintain the quality management system related to the exceptions and disposition processes based on cGMP, good documentation practice and relevant regulatory requirements.
You will interact with several onsite departments as well as all other QA functions in cross functional super user and alignment teams. These teams are established to ensure flexibility and to align our Quality mindset for the site.
- Perform QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records
- Engage in exceptions handling, approval of documentation and change controls
- Act as primary QA contact for the DSM Manufacturing Documentation team, Manufacturing Management, Manufacturing Science team, Engineering and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance.
- Participate in execution of audits and inspections and act as subject matter expert
- Involvement in challenging cases and projects
- You hold a Master of Science within Pharmacy, Biotechnology, Biology or similar.
- You have minimum 4 years of work experience within the pharmaceutical industry, preferably within Quality Assurance alternatively in Quality Control or in a Compliance function.
- You have solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry that allows for understanding of the complexity of manufacturing biologics. Experience from Automated manufacturing systems or electronic batch documentation is considered an advantage.
- Experience with process improvements is preferred
- Experience from QC is an advantage
- Fluent in English both verbally and in writing
You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders. You focus on details and deadlines but are able to keep an overview that enables you to take a holistic and pragmatic approach. You take ownership of your work and feel comfortable by independently resolving issues. You have solid interpersonal skills and enjoy cooperating with colleagues from different cultures, on all levels and from different functions with the focus of building a strong collaboration and trust in your network.
Please upload your CV and cover letter as soon as possible and latest by 14th of January. We will screen applications on an ongoing basis.