Regulatory Compliance Specialist in Biotech Document Management
3 days ago
We are seeking a detail-oriented Regulatory Compliance Specialist to join our team in Hillerød, Denmark.
FUJIFILM Diosynth Biotechnologies (FDB) is a leading Contract Development and Manufacturing Organization (CDMO) with sites worldwide. In our Hillerød location, we have approximately 1700 employees working on every aspect of biotech and pharmaceutical production.
The Drug Substance Manufacturing Support department consists of around 100 employees responsible for project management and compliance of procedures and documentation. Our DSM Documentation team provides procedural support to GMP manufacturing and ensures timely document release activities.
In this role, you will be responsible for:
- Coordinating various types of documents for DSM, such as BPRs, SLRs, logbooks, and handbooks
- Issuing documents and labels for DSM
- Reviewing BPRs and logbooks
- Creating and maintaining records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents
- Performing timely closure of action items to ensure reliable execution of production
- Continuously improving department processes and supporting stakeholder improvement projects
To succeed in this role, you will need:
- 2-5 years of experience in cGMP and pharmaceutical manufacturing
- A Bachelor's degree in engineering, science, pharmacy, or a similar field
- Knowledge of Cell Culture and Purification unit operations
- Fluency in English
FDB offers a competitive compensation package, including an estimated salary range of $60,000 - $90,000 per year, depending on experience. You will also enjoy a collaborative work environment, opportunities for professional development, and a chance to make a meaningful contribution to the company's success.
We value diversity and inclusion, and we strive to create a workplace where everyone can thrive. If you are passionate about regulatory compliance and have a strong work ethic, please consider applying for this exciting opportunity.
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