*Experienced Quality Assurance Scientist for QA for QC (Analytical Method Validation)
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QA OperationsQA 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 QC documentation, manufacturing activities and batch release.
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 QC and 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.
Your Tasks and Responsibilities:
As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment.
Your main responsibility will be to support QC and QA in the area of analytical method validation for late stage and commercial products, which includes:
- Close collaboration with QA and QC
- Guiding in requirements for commercial production support
- Review and approval of analytical method validation protocols and reports
- Change requests
- Deviations and CAPAs
We are a very communicative and a broad work player within QA and QC teams, so we cooperate closely with many 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, at least, 5+ years of experience within Quality Assurance and/or Quality Control, as it is key for this role to be proven experienced on analytical method validation in combination with regulatory requirements.
It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.
You have proven experience with Analytical Method Validation and other areas such as:
- Proven experience with requirements for commercial and/or late state clinical phase projects within GMP manufacturing, as well as with testing of biological intermediates, APIs and Cell Banks
- Complying with European Pharmacopoeia (Ph. Eur.) and U.S. Pharmacopeia (USP)
- Great communication skills as you’ll be engaging on a daily basis with internal & external stakeholders
- Skilled and experience with QA oversight of QC activities
- Used to be a lead on supporting or guiding QA and/or QC staff
- Experience with contract manufacturing and business understanding
- Deviation handling including root cause investigations
- Review and evaluation of QC documentation
You Are:
- Natural talent to lead work groups and functions within late stage projects
- Highly oriented to problem solving and handling different tasks at the same time
- Ability and agile to find solutions and deliver on expectations, especially considering our customer centric approach.
AGC is a global company and has a multitude international customers, and our official company language is English. It is therefore a required ability that communication in both written and spoken English is proficiently fluent.
AGC offers
AGC is 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.
Contact
Please send all applications via our career site. We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible. The job ad will close once we have found the right candidate.
For further information, please contact Max Woweries 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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 9.2.2022, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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