*QA Scientist
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AGC Biologics is looking for a QA Scientist for one of our QA teams covering products produced by microbial fermentation, subsequent purification and aseptic filling of Drug Substance. The position covers QA oversight as required by GMP in a manufacturing facility mainly producing commercial grade biological APIs.
QA Operations Microbial team
QA Operations Microbial team consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance.
We ensure that Manufacturing, Process Development/Transfer, Validation and Quality Control comply with the standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be an important collaborator in reaching this.
The team 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 Microbial 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 partners of AGC Biologics.
Reports directly to QA Manager.
The Role (daily responsibilities):
- Ensure resolution of quality issues together 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 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 Production Records
- Risk Assessments
- SOPs
- Supports deliveries related to 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
- Assist with the generation of 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 of GMP
- Strong decision making skills and ‘can do’ attitude
- Excellent written and verbal communication skills
- Ability to work in a fast paced, matrix environment is 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. Professional level written and spoken English is therefore a requirement.
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 6.3.2023, men kan have været deaktiveret og genaktiveret igen.
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- København
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