Scientist, QA, Facility and Equipment
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QA Facility and Equipment
QA Facilities and Equipment team 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 Facilities and Equipment team is to ensure that our production facilities and laboratories are in accordance with current standards for GMP production, at all times (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.
Develop your GMP skills and build relations with highly skilled people from the industry
You will cooperate closely with the other teams in QA and departments at AGC Biologics in CPH and with colleagues from our sister sites in US, Japan, Italy 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 and rebuild of the AGC 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.
Your Profile
You have experience with Quality Assurance of API manufacturing.
It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, engineering or similar.
Ideally, you have a minimum 5 to 7 years proven experience and knowledge within the following areas:
- Deviation handling including root cause investigations.
- CAPA and Change Control handling
- QA approval of qualification documents for:
- Facility, Utility and Equipment
- Computerized systems in cGMP manufacturing areas.
- Computerized systems in cGMP QC Laboratory areas.
- QA oversight of manufacturing activities and guidance of manufacturing staff.
- CFR 21 Part 11 and EUDRALEX Annex 11
- Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks.
- QA approval and provide training in SOPs
- Experience with Contract Manufacturing
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.
As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. qualifications of equipment, IQ, OQ, PQ related to facility equipment, Environmental Monitoring, Cleaning Validation, Deviation handling, Approval of CAPA and Change Requests
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.
AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
For further information, please contact Troels Risgaard at [email protected]
For agencies, please contact our Talent Acquisition team at [email protected]
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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 10.2.2022, men kan have været deaktiveret og genaktiveret igen.
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