Scientist, Quality Assurance

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Due to new projects and increasing activities the QA Operations team is looking for a QA Employee to assist with quality assurance of manufacturing activities and batch release of biological API for phase I-III clinical trials and commercial manufacturing. This position is especially target toward review of batch documentation on the shopfloor and therefore more of the working hours will be in the production area. This is a full-time permanent position.

QA Operations

QA Operations consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Operations team, the quality unit department consist of the teams Quality Systems and QA Facility and Equipment. The main responsibility of the QA Operations team is quality assurance of manufacturing activities, batch release and QC documentation.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

QA Shop Floor

The QA Shop Floor Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. Reports directly to QA Senior Manager.

The role (daily responsibilities):

  • Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
  • Provide an “on-line” Quality presence in the production area during manufacture with particular regard to on-line document and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
  • Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
  • Perform Quality review and approval of minor deviations.
  • Conduct batch record “Stage Approval” as part of batch release process
  • Participate in GMP walks through the production area
  • Work with production team to drive improvements in GMP compliance across all shifts
  • Shipping/ prepacking approval
  • Oversight of labeling process
  • Buffer and media review
  • Buffer MPR approval
  • Perform other duties as assigned

Education and experience

  • Minimum Science based degree
  • Substantial experience working in or directly supporting manufacturing within a drug product/ substance manufacturing site
  • Previous biopharma experience is preferred
  • Strong working knowledge of the principles and guidelines for GMP
  • Strong decision maker and ‘can do’ attitude
  • Excellent written and verbal communication skills to internal and external stakeholders
  • Ability to work in a fast paced, matrix environment is essential
  • Capable of working to deadlines and prioritizing multiple tasks
  • Flexibility to meet changing needs and priorities of the business
  • Experience working in a GMP aseptic manufacturing environment

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 18.2.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
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