Quality Assurance Scientist for QA Operations Shop Floor

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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 shop floor and therefore more of the working hours will be in the production area.

This is a 12-months temporary 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

As QA you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation.

Your main responsibilities:

This QA position is specially target toward quality support of production in the shop floor and include

  • Online batch review
  • Deviation support and approval
  • CAPA approval
  • QA Approval of Buffers
  • Approval of production rooms

A major part of the job will be on activities related to production documentation and Quality Assurance guidance of manufacturing staff.

There will be 1-2 evening shifts during the week.

We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.

Your profile

You have experience with GMP production of API and/or Adjuvant manufacturing.

It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology or similar or a technical background with a solid experience with-in GMP production.

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. 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.

For further information, please contact Niruja Sivasubramaniam at [email protected]

For agencies, please contact our Talent Acquisition team at [email protected]

#JobsForUkraine.

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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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 9.3.2022, 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.
  • Produktchef
  • København
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