id: NDk3NTczNSA3

reference: 4975735

documentId: 4975735

connectionPointId: 7

lastModificationDate: 1555331440900

stillingsbetegnelse:
QA Scientist for Supplier Management to Quality Assurance

jobbeskrivelse:

Do you want to develop our Supplier Quality Management system? We are looking for a skilled QA Scientist Supplier 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 who is responsible for approval and release of raw materials, internal and external audits, inspections from authorities, training and the Quality IT-systems for document handling and quality processes.

You will be responsible for ensuring that our suppliers are in a state of control and you will be the QA Subject Matter Expert on Supplier Management which includes:

• Development and maintenance of the Supplier Management Program

• Implementation of TrackWise as new Suppler Quality Management digital platform

• Qualification of suppliers

• Audit plan quality risk assessment

• Perform supplier audits and keep our suppliers in a state of control

• Write up and maintain Quality Agreements for our suppliers

• Participation during authority inspections from EMA, US FDA and other international authority

• Participation in customer audits and visits

• Participation in projects

 Furthermore, you will have responsibility for:

• 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:

• Experience as Lead Auditor

• +3 years’ experience from the Biopharmaceutical industry

• Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API

• Relevant academic background within pharmacy, biotechnology or similar

• Some travel should be expected

 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 positive and open minded

Deliver quality assurance of biopharmaceutical products and API

As QA Scientist 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 April 28, 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