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reference: 4912750

documentId: 4912750

connectionPointId: 7

lastModificationDate: 1543582865840

stillingsbetegnelse: Senior Quality & Validation Specialist

jobbeskrivelse:

Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Do your passion lies within ensuring the Quality, Compliance and Validation, as well as setting direction and advising and training colleagues? Then here is a great opportunity to join the office in Søborg, Denmark in our newly established Global Quality & Qualification Services Team. 

Your responsibilities as Senior Quality & Validation Specialist  

You will be part of the Global Quality & Qualification team in Søborg. The team consists of 6 dedicated and skilled colleagues located both in Søborg and Tianjin in China. Our overall objectives are planning and executing Qualifications and Validation both for GxP and non-GxP systems, ensuring IT Infrastructure projects are in compliance with the existing regulatory requirements within the Life Science industry, as well as with NNIT’s internal quality assurance and control requirements. Furthermore, as trusted advisors, our focus is also to increase quality & awareness across the Global Projects Organization through training and other strategic initiatives.   

Your primary responsibilities will be:  

• Organizing Quality Activities for Computer System Validation projects/activities (incl. areas related to Data Integrity/ER).  
• Facilitating and leading Qualifications .  
• Participating in projects as a Quality & Compliance advisor to ensure compliance and documentation requirements are met.  
• Reviewing IT project and operations documentation; ensure that process requirements are met according to internal QMS.  
• Identifying and implementing process improvements.  
• Help and assisting Line of Business with inspection readiness. Increasing quality awareness by training colleagues in regulatory requirements and NNIT’s Quality Management System.  

Your qualifications  You have a university degree or similar higher education and have a solid experience working with validated computer systems, GxP and Quality Management.   

You have experience working with one or more of the following; 21 CFR Part 11, PIC/S, Eudralex Annex 11 & 15, ISO9001 and have knowledge about GAMP5 framework. Furthermore it is an advantage if you have experience with ITIL or HP ALM (ver. 12).   

You communicate well in English; both oral and written (English is our corporate language)   

As a person you:  

• are structured in your daily work, self-motivated and able to take the initiative.  
• have effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.  
• are good at communicating and interacting with people.  
• prefer to work with various tasks simultaneously.  
• like to share your knowledge and help colleagues.  
• are used to work with creating and reviewing documentation.  

 We evaluate applications on a continuous basis, and therefore we encourage you to apply for the position as soon as possible.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2512

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: NNIT A/S

source: DK-STAR