IT QA Specialist
We are looking for an IT QA Specialist for our Human Health production sites in Roskilde and Avedøre. You will become part of our quality organization and report to our Human Health QA Operations Manager.
The division Health and Nutrition in Chr. Hansen develops and produces products for dietary supplements, pharmaceuticals, infant formula, animal feed and plant protection. Our present key offering is probiotic cultures with documented effect for both humans and animals. We drive continuous improvement activities, and as IT QA Specialist you will have a great impact on those activities.
In this position, you will be responsible for securing the quality of our products for Human Health (HH), which are probiotics for dietary-, infant- and pharmaceutical use and you will play a key role to define and implement IT QA practice and procedures in the organization.
QA Specialist with a strong IT focus
As IT QA Specialist your main responsibility will to be Subject Matter Expert (SME) for IT validation of shop floor systems within Human Health. This includes IT QA support to validation activities, batch records and general assurance of data integrity in production. This position navigates in a cross field between IT, business and QA and have a close cooperation with departments from these areas and many different stakeholders. Further you will participate as IT QA in relevant projects. Currently we are building a new packing facility in Avedøre and your first main task will be IT QA support for this project. Your main responsibilities will be:
- IT QA specialist on new green field packing facility in Avedøre.
- IT QA support for Automation and IT in quality related issues.
- Support and train the organization within the relevant quality requirements.
- Initiate, write and/or review SOP’s within your area of expertise.
- Approve validation documents, change documents, etc
- Participate in audits and inspections from customers, authorities and external certification bodies.
Good experience with IT compliance
You hold a master degree in Microbiology, Engineering, Food Science, Pharmacy or are in other ways qualified to understand our business. Furthermore, it is crucial that you have an operational mindset and that you have +10 years of experience of navigating in the cross field between business and IT.
As this role focusses on IT, you must be experienced, specifically within IT compliance - and validation and in IT systems supporting Life Science development and production. Preferably, you also have knowledge about production processes as fermentations, freeze drying and packaging, within qualification and validation of equipment. In addition, you have relevant knowledge on GMP requirements and regulatives (e.g. Eudralex-annex 11, FDA 21 CFR part 11, ICH, GAMP5, Dietary supplements regulations etc.
It is important that you thrive within an ever-changing environment and a complex mix of products and regulatory requirements and that you have the ability to act autonomously, balancing and prioritizing the tasks and demands in the role. Finally, as you will be working cross-organizationally, you will need all of your ability to collaborate and create sustainable relationships – across cultural, professional and geographical borders. This takes very good communication skills in English, written and spoken.
A challenging and rewarding position in a global company with long-standing experience within product safety and employee development. You will become part of the Human Health QA Operation department of six highly skilled and motivated colleagues. The Human Health area in Chr. Hansen is growing and currently the QA Human Health area covers approx. 20 QA specialists and coordinators organized in four departments reporting to the Director of Human Health QA.
This Position is placed in Avedøre and Roskilde, with expected meeting activity at both Avedøre, Roskilde and Hørsholm. Therefore you need a driving license and your own car to be able to commute between sites.
If you have any questions for the position, please feel free to contact Annika Knoesgaard Mogensen, HH QA Operations Manager at +45 52 18 01 82 / email@example.com or Christina Scheel, HH Quality System Manager at +45 22 76 62 92 /firstname.lastname@example.org.
Please apply online via "Apply now". Here you can enter your details into our CV-bank.
Deadline for application is the 31th of March 2018. As applications will be reviewed on an on-going basis we encourage you to apply as soon as possible.
Read more about working for Chr. Hansen at: www.chr-hansen.com/career.
Chr. Hansen is a global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. The products include cultures, enzymes, probiotics and natural colors, and all solutions are based on strong research and development competencies coupled with significant technology investments. Revenue in the 2015/16 financial year was EUR 949 million. The company has more than 2,800 dedicated employees in 30 countries and main production facilities in Denmark, France, USA and Germany. Chr. Hansen was founded in 1874 and is listed on Nasdaq Copenhagen. For further information, please visit www.chr-hansen.com.