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QA Operations
QA Operations consists of two sub teams with the main responsibility of quality assurance of manufacturing activities and batch release of mammalian recombinant manufacturing of drug substances (API).
AGC Biologics is a CDMO and covering international pharma customers. We manufacture a big range of drug substances from clinical to commercial.
The two sub teams are scientists and principal scientists with various professional backgrounds and years of experience.
The department has an open communication with a focus on a high level of professionalism. We are open-minded and have a high service level for our colleagues in the rest of the AGC Biologics organization - and not least for our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.
We actively work within our field of understanding- and interpreting legislation to ensure manufacturing is in compliance with current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines. Continuously we improve our standards within quality- and manufacturing processes, innovate with modern technology and our common value chain with internal stakeholders.
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 the QA Manager.
The Role/daily responsibilities):
- 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 Production Records
- Risk Assessments
- Support the generation of new, as well as 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
- Assist with the generation of APQR (Annual Product Quality Review)
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:
- You have 2 years of experience with Quality Assurance.
- A science-based Master’s degree or equivalent.
- 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 making 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 prioritizing multiple tasks.
- Flexibility to meet the 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.
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 15.12.2023, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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