Compliance Associate (Supply Chain)
About the department
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.
About the role
Your daily tasks as Compliance Associate will include:
- Ensure compliance of Supply Chain GMP documents and improvement of the compliance level of Supply Chain processes in accordance with the requirements defined in the Pharmaceutical Quality System (PQS)
- Initiate and assess impact/risk of exceptions and Change Management Requests.
- Track and trend on exceptions and efficacy of corrective actions. Support management to ensure timely action and closure of records
- Establish and implement corrective and preventive actions to mitigate risks, prevent re-occurrence and improve compliance.
- Support Customer Complaints process
- Support preparation of audits and inspections
- Support optimization projects and drive smaller optimization projects to ensure continuous improvement of Supply Chain processes
- Key quality systems super user representing Supply Chain, working in close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
Qualifications and Education
- Bachelor or Master’s Degree within Pharmaceutical Sciences, Process 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 structured with a quality mind set. You enjoy working independently in a dynamic environment and are comfortable interacting with stakeholders from different business areas.
Please upload your CV and cover letter.
Working at FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA.
We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout.
Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
Our large scale manufacturing facility in Hillerød has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.