Process Supporters for our Compliance Support team in Manufacturing

Are you driven by quality and compliance in a fast-paced manufacturing environment?Are you motivated by collaborating closely with our shop floor teams to own deviations, CAPAs, and audits while elevating GMP/QMS performance and creating lasting improvements?Then join our Compliance Support team and help secure our License to Operate.About The RoleYou’ll collaborate with managers and operators to ensure our GMP level. A key part of your role will be understanding the QMS system and completing all GMP/QMS related tasks in a timely manner and of high quality. Your main tasks include handling deviations and changes (delimitation, corrective & preventive actions, qualification, etc.), doing GEMBA walks, writing and updating SOPs, etc.Your efforts will directly help us meet our goals by ensuring a high compliance level in the department.Job Responsibilities (not limited to)Your Initial Primary Tasks Will BeCollaboration with production on siteWriting deviations using SPS with A3 toolFacilitate A3 meetings and Investigate root causesDaily Shopfloor in productionClassification of deviations picked up on shop floorPreparing, writing CAPA`s for board presentationClosing deviation in time for batch releaseParticipating in audits/inspections where relevantGeneral support with compliance related tasksFuture TasksOther GMP related tasks such as changes, SOP & Work Instructions creation & maintenance, etc.Drive and coordinate quality improvementsSupport GMP training and contribute to the understanding of GMP in the departmentParticipation in ad hoc projectsQualificationsWe are looking for a candidate with the following background and skill sets:Professional QualificationsEducational background is minimum a Bachelor within engineering, science, pharmacy or similar.Experience with cGMP and pharmaceutical manufacturing, preferably 2+ years in the industry.Preferably knowledge about API production using recombinant protein expression.You are familiar with complex quality processes and have experience from regulated GMP areas.Analyzing data and creating complicated overviews and visualizing data driven patterns.Excellent business communication skills, both in Danish and English. Personal QualificationsWe’re looking for someone who takes responsibility and ownership - someone who acts and is proactive, who thrives in dynamic setting where things go fast. You can easily tackle challenges, and your positive mind and 'can-do' attitude helps you thrive in challenging situations, ensuring effective collaboration and smooth operational workflows. You enjoy optimizing production efficiency.You are structured and responsible, with excellent Quality & Compliance skills. As a problem-solver with a solution-focused mindset, you excel in building strong teamwork and relationships.Lastly, if you see yourself as a high performing team player who is ambitious on behalf of yourself and the company, then you might be just the candidate, we are looking for!About The Department/TeamThe Compliance department comprises 3 sub-teams and in total around 22-25 full-time employees and is a dynamic group of professionals, ranging from newly joined to very experienced, all dedicated to supporting the Up- and Downstream production.The department plays a crucial role in ensuring that deviations and CAPAs are completed at the right time and quality. By joining this very dynamic department, you will be able to influence the way we work with Quality & Compliance.Our EnvironmentExperience an international, informal, and vibrant workspace where psychological safety, trust, and empowerment are paramount. Share in our pursuit of life balance and camaraderie, making strides alongside a nurturing and ambitious team. ApplicationApply by sending your updated CV and Cover Letter today.Working at FUJIFILM BiotechnologiesWe offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.FUJIFILM 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 Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. 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.FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.