Experienced Quality Assurance Specialist in Drug Product Manufacturing

Job title:

Experienced Quality Assurance Specialist in Drug Product Manufacturing

Company:

Fujifilm

Job description

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 RoleJoin 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.

QualificationsWe 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 qualificationsAs 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.ApplicationIf 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 Louise Olsen, at .Even if you don’t meet all the criteria but believe you can contribute meaningfully to our team, we encourage you to apply.We encourage you to bring your full self to work every day, as we value everyone’s unique talents, diversity, and strengths through mutual trust. So just be you!About FUJIFILM Diosynth BiotechnologiesFUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.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.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.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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Thu, 06 Mar 2025 23:20:20 GMT

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