Senior QA for QC specialist

Fujifilm

  • Hillerød, Hovedstaden
  • Permanent
  • Fuldtid
  • 7 dage siden
Would you like to be the go-to expert for QA in a laboratory setting, ensuring flawless compliance and quality in every project?And can you elevate our QC processes by skillfully managing documentation, changes, and deviations while fostering a culture of excellence?"Then we hope you are our new colleague!Your New RoleYou will be the main QA contact for the QC laboratory in all their activities. You will have the responsibility of reviewing and approving QC relevant documents, equipment alarms, changes and deviations. Furthermore, you will engage proactively with QC to enhance compliance and secure quality oversight support in general.Primary Responsibilities
  • Perform QA support to QC; Review and approve QC related documentation
  • Assess and approve changes and deviations related to QC activities
  • Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported. Act as quality partner by providing guidance, training and ad hoc support to stakeholders herewith
  • Represent QA for QC on assigned projects related to QC
  • Take part in local and potential future global alignment tasks within QA for QC
  • Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications
Skills & Talent
  • Bachelor or Master of Science in natural science, e.g. Pharmacy, Biotechnology, Biology, Engineering or similar
  • 3+ years of work experience or educational background that allows for understanding of the complexity of manufacturing biologics
  • Preferably experience with overseeing quality of deviations
  • Speak and write English fluently
  • Well-versed in GxP guidance and knowledge of quality systems
We hope you areA self-driven and excellent communicating team player with a keen eye for creating structure while thriving in a very dynamic environment.If you do not match all the above-mentioned criteria, but believe you have something to contribute with and still find the position interesting, then please send your application.Your New Team & DepartmentCurrently the team consists of 9 persons and is further a part of a larger QA organization which provides quality support to production of batches in drug substance manufacturing, filling of drug product and Assembly, Label and Pack. QA for QC is a dynamic team that has close collaboration with multiple internal stakeholders and QA colleagues.We are team players, entrepreneurs, and people who both like details and like taking greater responsibility beyond your scope of work.The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.ApplicationHas this sparked your interest? Then please upload your CV and cover letter as soon as possible as we screen candidates on a continuous basis and call in for interviews. If you have any questions, please do not hesitate to reach out to Manager Joachim Karlsen +45 41945445FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.Shape the future with us—your drive meets boundless opportunity hereFUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, 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.

Fujifilm