QA Specialist for Facility and Equipment
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Søborg
The QA Facility and Equipment team is looking for a QA Specialist to assist with quality assurance of manufacturing activities, qualification of equipment and validation activities of biological API for phase I-III clinical trials and commercial manufacturing.
QA Facility and Equipment
QA Facility and Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Facility and Equipment team, the quality unit department consist of the teams Quality Systems and QA Operation.
The main responsibility of the QA Facility and Equipment team is to ensure that our production facility and laboratories at all times are in accordance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.
We are actively involved in the constant development within our field and the continuous improvement of our quality system and Facility.
You will cooperate closely with the other teams in QA and departments at AGC Biologics in Copenhagen and with colleagues from our sister sites in US, Japan and Germany in order to ensure that all quality related activities are carried out LEAN, effectively and in compliance with cGMP.
Through customer projects, audits and inspections as well as continuous improvements of the facility and processes, you are exposed to a lot of different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers.
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 team is characterized by a positive and proactive environment colleagues working together in committed and friendly collaboration.
QA Facility and Equipment
QA Facility and Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Facility and Equipment team, the quality unit department consist of the teams Quality Systems and QA Operation.
The main responsibility of the QA Facility and Equipment team is to ensure that our production facility and laboratories at all times are in accordance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.
We are actively involved in the constant development within our field and the continuous improvement of our quality system and Facility.
You will cooperate closely with the other teams in QA and departments at AGC Biologics in Copenhagen and with colleagues from our sister sites in US, Japan and Germany in order to ensure that all quality related activities are carried out LEAN, effectively and in compliance with cGMP.
Through customer projects, audits and inspections as well as continuous improvements of the facility and processes, you are exposed to a lot of different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers.
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 team is characterized by a positive and proactive environment colleagues working together in committed and friendly collaboration.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 18.6.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Søborg
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