Quality Assurance GMP Specialist
AAK Sweden AB / Organisationsutvecklarjobb / Karlshamn
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hela Sverige Visa alla jobb hos AAK Sweden AB i Karlshamn Everything we do is about Making Better HappenTM.
AAK specializes in plant-based oils that are the value-adding ingredients in many of the products people love to consume. We make these products better tasting, healthier, and more sustainable. We enhance their sensory experience - by giving the silkier mouthfeel in premium chocolate, the juicier texture in a plant-based burger, and the puffier appearance in a lower-fat pastry. We can also optimize their production by substituting existing ingredients with plant-based equivalents that give better efficiency. AAK's value-adding solutions enable our customers to be successful in a better way.
At the heart of AAK's offer is Customer Co-Development, combining our desire to understand what better means for each customer, with the unique flexibility of our production assets, and a deep knowledge of many products and industries, including Chocolate & Confectionery, Bakery, Dairy, Plant-based Foods, Special Nutrition, Foodservice and Personal Care. Our 4,000 employees support our close collaboration with customers through 25 regional sales offices, 15 dedicated Customer Innovation Centers, and with the support of more than 20 production facilities.
Listed on Nasdaq Stockholm and with our headquarters in Malmö, Sweden, AAK has been Making Better HappenTM for more than 150 years.
About the position
The GMP Specialist is part of the Quality team at site Karlshamn and collaborates with production, engineering, quality control laboratory, purchasing and other functions to make sure we have the right quality for our products and customers. The Quality Assurance GMP Specialist assures compliance with regulatory requirements and internal company procedures for products manufactured in our production process for Active Pharmaceutical Ingredients.
The work as a GMP specialist will be focused on driving continuous improvements of site quality systems as well as being involved in QA tasks within the GMP area.
The position is full-time, and you will be based in Karlshamn, Sweden.
Main responsibilities:
• Coordinate continuous improvements initiatives within the GMP area
• Perform batch record reviews including quality control record review and product disposition
• Release of API product, starting material, raw materials and process aids
• Issue Certificate of Analysis for released batches
• Evaluate non-conforming products and ensure handling of customer complaints
• Perform Product Quality Review
• Manage change control within GMP area
• Perform internal inspections (EU-GMP part II, ISO9001 and FSSC22000)
• Participate in audits and inspections from customers, authorities and notified bodies
• Perform internal trainings
Who are you?
To be successful in this role you have a university degree in chemistry, engineering or other relevant subject and you have at least 3 years of working experience from Quality in a regulated environment, preferably from a pharmaceutical company. A proven understanding of quality systems regulations, cGMP (ICHQ7/EU GMP part II) is required. Knowledge/experience from food or cosmetic industry is an advantage.
We value good cooperation skills, that you are driven, can deliver and prioritize your work based on set goals. We expect you to have the right skills to perform tasks accurately without continuous supervision but seeking input from others as needed. Furthermore, you have to have strong project management skills and you should have engagement in quality and have the ability to communicate with authorities, customers and people on different levels within the organization. You enjoy working both independently and in a team.
Contacts and application
For further information about the position please contact Quality Manager Camilla Folger, phone no +46(0)76 0262051 or email
camilla.folger@aak.com.
For further information about the recruitment process please contact HR Business Partner Karl Lindqvist,
karl.lindqvist@aak.com.
Please submit your application with relevant enclosures soonest possible as applications are evaluated continuously. Last day for application is 2023-08-01 Applications via email are not accepted.
We have already chosen our sourcing channels for this recruitment and kindly ask not to be contacted by any advertisement agents, recruitment agencies or manning companies.
Så ansöker du Sista dag att ansöka är 2023-08-01
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare AAK Sweden AB (org.nr 556478-1796)
Västra Kajen (
visa karta)
374 82 KARLSHAMN
Jobbnummer 7876479
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