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Chr. Hansen A/SWe are looking for a QA Specialist for our Human Health production sites in Roskilde and Avedoere. You will become part of our quality organization and report to our QA Operations Manager located in Human Health QA. You will be responsible for securing the quality of our products for Human Health (HH), which are probiotics for dietary-, infant- and pharmaceutical use. Your tasks As a production’s partner on cGMP related issues your main task is to ensure Human Health quality system efficiency and secure the appropriate quality level for our processes and products. This means you will be dedicated to deviation handling, change control, SOP updates, and validation. Your main responsibilities QA partner for production departments to support and guide in quality related operation issues like deviation handling, change controls etc. QA on validation and qualification projects for production equipment and utility Participate in audits from customers, authorities and external certification bodies Support and drive quality related projects in the organization, mainly in production areas Initiate, write and/or review SOP’s within your area of expertise Ensure training within your area of expertise Ensure §39 in relation to Eudralex (Vol 4, Vol 2. and Annex 15) and ISO/FSSC22000 certification Your professional profile You hold a master degree in Microbiology, Engineering, Food Science, Pharmacy or in other way qualifying for a GMP QA You have more than 5 years of experience from the pharmaceutical industry or from production of dietary supplements You are solution oriented with a combined focus on details and the whole value chain You have relevant knowledge on cGMP regulatives (Eudralex), Dietary supplements regulation (FDA 21 CFR part 111) and ISO/FSSC 22000, ISO 9001 You have knowledge about production processes as fermentations, freeze drying and packaging You must be able to write and speak both Danish and English on a professional level Your personal profile You master the balance of close cooperation with your production partners as well as setting and communicating quality requirements You thrive within a very changing environment and within a complex mix of products and regulatory requirements You are self-driven, like to create overview and to prioritize, communicate and act on that You are a real team player with a good sense of humor and can easily socialize with many different persons We offer 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 with 5 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 3 departments reporting to Director of Human Health QA. The position is placed in Roskilde, with expected meeting activity at Avedoere and Hoersholm. 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, HHN QA Operations Manager at +45 52 18 01 82 or [email protected]. Please apply on-line. Here you can enter your details into our CV-bank. Deadline for application is the 19th of May 2017. As applications will be reviewed on an on-going basis we encourage you to apply as soon as possible.
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