*QA Scientist

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The QA Operations team is expanding and is looking for an experienced QA scientist to assist with quality assurance of commercial approved products in the US and EU.

QA Operations
QA Operations consists of highly qualified technicians and scientists with various professional backgrounds and several years of experience within Quality Assurance.

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 and QC activities 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 service 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.

Tasks and Responsibilities
The QA Scientist provides customer service, with the highest integrity, focused on quality and compliance with partnership with AGC Biologics.

Reports directly to Senior QA Manager.

The Role (daily responsibilities):

  • Provide a single primarily point of contact for the client(s) on quality related topics,
  • Ensure resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patient’s safety,
  • Responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to:
    • Change controls;
    • Deviations,
    • CAPAs,
    • DS specifications,
    • Master Batch Records,
    • Risk Assessments,

  • Support the generation of new and improvement of existing department SOPs,
  • Support delivery of AGC projects,
  • Work with management to resolve project issues and resource constraints within the team,
  • Support client audits as necessary,
  • Assist with negotiation terms of Quality agreements with the client as required,
  • Liaise with the internal and external stakeholders to resolve and clarify any point of issue,
  • Generate APQR (Annual Product Quality Review), if required,
  • Perform other duties as assigned,

Your Profile
It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.

Education and experience

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

AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

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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 28.7.2022, men kan have været deaktiveret og genaktiveret igen.

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