Process Supporters For Our Compliance Support Team In Manufacturing

Compliance Support Team Member

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 Role

You'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.

Responsibilities

Your initial primary tasks will be:

• Collaboration with production on site
• Writing deviations using SPS with A3 tool
• Facilitate A3 meetings and Investigate root causes
• Daily Shopfloor in production
• Classification of deviations picked up on shop floor
• Preparing, writing CAPA`s for board presentation
• Closing deviation in time for batch release
• Participating in audits/inspections where relevant
• General support with compliance related tasks

Future tasks:

• Other GMP related tasks such as changes, SOP & Work Instructions creation & maintenance, etc.
• Drive and coordinate quality improvements
• Support GMP training and contribute to the understanding of GMP in the department
• Participation in ad hoc projects

Qualifications

We are looking for a candidate with the following background and skill sets:

• Educational 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 Qualifications

We'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/Team

The 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 Environment

Experience 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.

Application

Apply by sending your updated CV and Cover Letter today. Working at FUJIFILM Biotechnologies

We 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.