Experienced QA Validation Professional for Drug Substance

Job title:

Experienced QA Validation Professional for Drug Substance

Company:

Fujifilm

Job description

Passionate about quality and validation and looking for a change?
At FUJIFILM Diosynth Biotechnologies, an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Here you will have the chance to enthusiastically develop, thrive and prosper in a professional environment among experienced scientists, engineers, and operators who are committed to help and impact people’s lives.The Role and your Qualifications
In an expanding business, the Drug Substance (DS) QA department is seeking an experienced individual, with knowledge working in a GMP environment with Quality Systems, Good Documentation Practice, and pharmaceutical legislations. You hold a university degree in a scientific field such as Biotechnology, Pharmacy, Medicine, Chemistry, Biology or similar.To better observe and learn, overcome challenges, make improvements, and participate in constructive discussions cross-functionally, we highly appreciate what we call GEMBA.This is basically to drive a be-there, go-see attitude when collaborating with our primary stakeholders in our daily tasks.The essential functions related to this role are listed below, but not limited to:

• Review and approval of

• validation protocols (IQ, OQ, PQ & PV) for utilities, equipment, and instruments
• Incidents (events/deviations), CAPAs and Change Controls
• Provide Quality Oversight for Validation
• Represent QA during Risk Assessments
• Ensures systems, equipment and processes are validated in a compliant manner in accordance with FDA, EU and site requirements
• Act as one of the primary QA contacts for the Validation department
• Participate in execution of audits and inspections and act as a subject matter expert
• Assist in the training of and alignment with colleagues
• Support continuous improvement initiatives

On top of that, there will be opportunities to be the QA partner when bringing in new products from existing or new customers through tech transfers and projects.About the DepartmentAs a valued member of the DS QA Operations department, you will thrive in this role if you enjoy a lively and dynamic work environment engaging in activities spanning manufacturing operations and projects.Our department is experiencing robust growth and currently consist of approximately 40 people. We put teams over hierarchy by structuring the department into Up- and Downstream, with close partnership with our DS QP-team where daily interactions support and develops professional and personal engagement across the teams.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!Application
If you have read this far and want to pursue this opportunity, then please upload your CV and cover letter as soon as possible.We will be conducting interviews on an on-going basis.

Should you have any questions, please feel free to reach out to Alexander Overby ( ), Manager in DS QA Upstream.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.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 Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Sun, 16 Feb 2025 04:24:56 GMT

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