Experienced Quality Assurance Specialist in Drug Product Manufacturing

Are you looking for a role where you can play a vital part in drug product manufacturing? Join our Drug Product Quality Assurance team as we transition from QA project support to achieving operational excellence in 2025 and beyond.

In this role, you'll be involved in essential tech transfer projects, influence quality standards, prepare setups for batch review and release, and work closely with key stakeholders to transition our new drug product facility into full production mode. We're seeking a dedicated professional eager to strengthen our quality assurance processes and support our facility's success.

About the Role

Join Fujifilm Diosynth Biotechnologies, Denmark, in a transformative journey as a member of our Drug Product Quality Assurance operations team. We are seeking an experienced Quality Assurance person to help drive our progress as we establish our first aseptic Drug Product facility.

As a team member, you will play a key role in this transition, moving from project QA support to operational QA support in the Drug Product Manufacturing area.

Your responsibilities will include preparing for regulatory approvals, supporting tech transfer projects, and participating in batch review and release activities. You will also review and approve SOPs, deviations, change controls, and protocols for APSs (Aseptic Process Simulations) and PPQs (Process Performance Qualification).

Additionally, you'll work on optimization projects and help address any areas where QA support is needed.

This role provides an exciting opportunity to help shape our QA processes and define quality standards in the DP area as the team develops in the coming years. If you're ready to contribute to and grow within this dynamic environment, we encourage you to apply.

Our Drug Product QA team, led by Maria Louise Olsen, currently consists of seven team members and is part of the QA organization, reporting to the Associate Director for Drug Product & Finished Goods.

We are in a formative stage, establishing our quality values and defining processes as we transition into new DP QA operational roles.

As we embark on this journey, team members are energized by bringing processes under control and adapting to our start-up phase. We prioritize high-quality standards and GMP compliance through close collaboration with our stakeholders. Our team is engaged in both DP QA operational activities and the QA approval of equipment, utility, and facility validation documentation.

We work with international QA teams for, ensuring a proactive and cooperative approach across all initiatives. Joining us means contributing to a dynamic and evolving environment where your impact on quality assurance is both valued and essential.

This role offers an adaptive list of tasks and responsibilities that can be influenced by your previous experience and interests. A common goal for all tasks is to support the creation of seamless everyday processes and foster collaboration with our stakeholders.

• Provide QA oversight for Aseptic Process Simulations.
• Conduct quality walks and ensure compliance.
• Review and approve incidents, CAPAs and change management records.
• Set up QA/QP related training.
• Drive QA-led enhancement projects and support other projects driven by other departments.
• QA support in tech transfer project for bringing new products from existing or new customers.
• Review and approve Batch Production Records.
• Review and approve Risk Assessments.
• Approve Facility alarms.
• Support inspection readiness and participate in partner audits.

Qualifications

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

Professional qualifications

• Master's degree in pharmacy, chemical engineering, or a related field.
• Minimum of 3 years' experience in a QA role within the pharmaceutical industry.
• Experience with filling and/or visual inspection processes and aseptic production.
• Proficiency in English, both spoken and written.
• We also positively evaluate profile with knowledge of equipment qualification processes
• Well-versed in GxP guidelines and quality systems knowledge.

Personal qualifications

As a person, you bring openness and energy to your tasks and interactions with colleagues. With a self-starting attitude, you possess a flexible and dynamic approach to challenges. You have the ability to work in a dynamic environment and thrive building the road as we go.

Application

If you are interested and ready to take the next step, please upload your CV and cover letter at your earliest convenience. We will conduct interviews on a rolling basis. If you have any questions, feel free to contact our DP QA Manager, Maria