id: NDk1OTQ5NyA3

reference: 4959497

documentId: 4959497

connectionPointId: 7

lastModificationDate: 1552479473496

stillingsbetegnelse: QA Technician for Quality Assurance Systems

jobbeskrivelse:

We are looking for a skilled QA Technician Materials & Quality Systems to join our QA 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 approval and release of materials, supplier management, internal and external audits, inspections from authorities, training and the Quality IT-systems for document handling and quality processes.

Your primary responsibility is to ensure that materials are in compliance and released for production which includes:

• QA release of materials
• Prioritization of release flow in close collaboration with warehouses
• Approval of deviations, CAPA and change requests
• Approval of specifications
• Quality aspects in relation to suppliers
• Participation in projects
• Participation during authority inspections from EMA, FDA and other international authorities
• Participation in customer audits

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:

• Support and organize activities around document control, staff training, deviations, CAPA and Change Requests
• Subject Matter Expert on key SOPs related to your area of responsibility
• Facilitate that the Site is kept in a state-of-control

Skills needed:

• QA Technician or other relevant experience
• +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:

• Be a team player
• Take responsibility for own tasks
• 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 Manager 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 March 24, 2019.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: AGC Biologics A/S

source: DK-STAR