We are looking for a Quality Program Manager who can support and represent Fujifilm Diosynth Biotechnologies Hillerød (FDBD) in QA collaboration projects with partners
About the position
In this role your primary tasks will be:
- To act as primary QA contact for external customers and partners in regards to day-to-day operational activities and for all Fujilfilm Diosynth Biotechnologies Denmark project teams involved in the partner collaboration
- To support technology transfer, process performance qualifications and manufacturing activities
- To adhere to the global quality system and support Drug Substance Manufacturing and Finished Goods Manufacturing organization in appropriate handling of tasks in accordance with Quality Agreement
You will also support the review and approval of documentations, deviations, CAPAs etc. in connection with partner programs and support in assessing all changes related to the partner programs to ensure a proper review of such changes for impact to regulatory requirements and product quality.
Furthermore you will perform timely QA review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols/reports, risk assessment and sampling plans.
FDBD Quality Partner Management team contains of 3 people that covers Drug Substance manufacturing, Finished Goods manufacturing and QP disposition activities performed at Hillerød site. The team works closely with all internal stakeholders and QA colleagues. It is a dynamic team that daily has close collaboration and communication with the customer. The Partner management team is part of a bigger QA operation organization.
About your qualifications and competences
- Degree in Natural Science
- Minimum 1-3 years relevant QA and/or manufacturing experience from the pharmaceutical industry.
- Knowledge of GMP quality systems.
As a person, you are organized with an attention to detail and still able to keep an overview
- You are service minded with excellent verbal and oral communication skills
- You have an ability to work independently
Please upload your CV and cover letter as soon as possible and latest by January 19th of 2019.