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We are looking for a skilled QA Technician with a strong interest in Audit and Inspection Management to join our QA Systems department. The challenging position has a broad variety of responsibility areas across the biopharmaceutical manufacturing process and quality systems. You will join a team where you will have great opportunities to influence, change and improve processes.
You will be part of the QA Systems department which is responsible for internal audits, customer audits and inspections from authorities. Furthermore, the department is also responsible for the Quality IT-systems for document handling, quality processes, training system, supplier management and release of materials.
This role will together with nine highly dedicated quality specialists be the backbone the Quality Management System and your primary responsibility is:
- Internal audit program and lead for execution of internal audits
- Preparations for inspections and audits
- Back Office during inspections and audits
- Responses to inspections and audits
- Surveillance of new relevant legislation and guidelines
- Participation in customer audits
- Participation during authority inspections from EMA, US FDA and other international authorities
- Participation in quality projects
Furthermore, the department is responsible for ensuring that our Quality System is in a state of control and based on your qualifications you will have responsibility for:
- Supporting Quality System processes such as document management and training system
- Subject Matter Expert on key SOPs related to your area of responsibility
Skills needed:
- QA Technician or other relevant experience
- Experience with Audit Management
- +3 years’ experience from the Biopharmaceutical Industry
- Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API
You must:
- Have flair for Audit Management and IT Systems
- Be a team player and ready to learn new things
- Take responsibility for own tasks.
- Result oriented and able to work towards deadlines
- Have high service level for both internal and external customers
- Have good communication and empathy skills
- Be flexible and pragmatic
- Be structured and systematic
- Be comfortable with MS office
- Be positive and open minded
Deliver quality assurance of biopharmaceutical products and API
As QA Technician you will play a key role in bringing numerous pharmaceutical productions safely, efficiently and compliant to market. You will become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time.
You will cooperate closely with the other teams in QA and departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. Through internal and external audits, you are exposed to 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.
Our Quality System is compliant to ICH Q7 and US FDA 21 CFR part 11, 210, 211, 600 and 610.
Join an international and agile organization
At AGC, you will get great opportunities to work with a varied array of tasks and challenges. You will get experience with our various departments as well as exciting and challenging assignments, Furthermore, you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where high energy and enthusiasm 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 regarding the position, please do not hesitate to contact Director QA Systems Erik Zobel, telephone +45 30 76 52 22 or HR business partner Niels Carlsen, telephone +45 23 34 61 56.
The applications will be processed continuously, so please apply as soon as possible and no later than January 17, 2020
.....................................................................
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.
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 23.12.2019, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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