We are looking for a new colleague in the Supply Chain organisation to provide support in all compliance and GMP related matters. The position will be placed in a newly established SAP Master Data Management team and will report to the SAP Master Data Manager.
The Supply Chain organisation consists of 50 dedicated colleagues with a broad variety of educational backgrounds. Supply Chain consists of team covering Planning, Sourcing, Strategic Planning & Analytics, SAP Master Data and Warehousing. We support all the teams with handling of deviations and CAPA’s, document updates, Changes, Audits and optimization & tech transfer projects. We have a close collaboration with the Supply chain teams and the customers to Supply Chain with 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:
- Ensure compliance of GMP documents and improvement of the compliance level
- Initiate deviations and Change Management Requests
- Establish and implement corrective and preventive actions to prevent re-occurrence and improve compliance.
- Support preparation of audits and inspections
- Support optimization projects and drive smaller optimization projects to ensure continuously improvement of Supply Chain processes
- Close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
Qualifications and Education
- Bachelor or Master Degree within Pharmaceutical Sciences, Proces Engineering or similar area
- You have a minimum 3 years of 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 Supply Chain, QA and Manufacturing.
- 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 structuredwith a quality mind set. You enjoy working independently in a dynamic environment.
Please upload your CV and cover letter latest by 9th of February 2020.
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.