Compliance Associate for Finished Goods Manufacturing
We are looking for a new colleague for the Compliance team to provide support to Finished Goods Manufacturing in all compliance and GMP related matters.
The scope of the FGM Compliance team is to:
- Support reliable and compliant production execution
- Optimize internal production setup & processes
- Ensure production execution according to relevant country GMP regulations
- Perform compliance SME assessments for FGM production related requests
- Execute and support successful audits
The Compliance supports the Finished Goods Manufacturing with batch preparation & review, handling of deviations and CAPA’s, document updates, Changes, Audits and Optimization projects. We have a close collaboration with the production teams and QA, and we have many cross functional assignments. This makes it a very exciting team to be part of, if you thrive in an environment where stakeholder collaboration is key. You will be part of a team that is very competent and works with a high independence.
Your daily tasks as Compliance Associate will include:
- Work with data and systematic problem solving to identify and drive improvements processes
- Initiate deviations and perform assessment of Finished Goods changes
- Establish and implement corrective and preventive actions to prevent re-occurrence and improve compliance.
- Ensure compliance of GMP documents and improvement of the compliance level
- Support and drive optimization projects to ensure continuously improvement of Finished Goods Manufacturing Processes
- Close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
Bachelor or Master Degree within Pharmaceutical Sciences, Proces Engineering or similar area
You have GMP experience from the Pharmaceutical or Biotech industry. You can work independently on compliance related issues, deviations and optimization projects. You have knowledge and experience with interface between QA and Manufacturing. You understand and are able to execute against regulatory requirements. You have a good level of technical writing skills and excellent communication skills in English and Danish (spoken and written).
As a person you are able to prioritize tasks to meet defined timelines. You work analytical and structured with a quality mind set. You enjoy working independently in a dynamic environment.
Please upload your CV and cover letter latest by 6th of December 2020. Interviews will be held throughout the application period.
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.
As part of FUJIFILM Diosynth Biotechnologies , you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, your family and your professional growth.
FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.