regulatory affairs specialist for akzo nobel salt in hobro

posted
job type
permanent
apply now

job details

posted
location
hobro, nordjylland
job category
Other
job type
permanent
reference number
5331
phone
+45 4024 5185
apply now

job description


Randstad is seeking for an ambitious Regulatory Affairs Specialist for the Quality department on behalf of our client, Akzo Nobel Salt A/S in Mariager.

About Akzo Nobel Salt


Akzo Nobel Salt A/S is the only manufacturer of salt in Denmark, with one of the world's most innovative and efficient evaporation plants in Mariager. The company has 140 employees and produces 600,000 tons of salt, which is used for foodstuff, consumer salt, pharmaceutical salt for the pharmaceutical industry, road salt and salt for the chemical industry. 50% of the production is exported, mainly by ship from the factory's own port to the other Scandinavian countries. Akzo Nobel Salt in Mariager is a part of Akzo Nobel, which is one of the world's leading salt manufacturers. The products are used within the electrolysis industry, gritting/salting and food and pharmaceutical industries among other things. Akzo Nobel Salt A/S’ head office is in the Netherlands and has more than 100 years of experience within their field. Akzo Nobel is existing on a global scale and has factories, sales-, and distribution centers in more than 80 countries. The group has approximately 45,000 employees. Read more at www.akzonobelsalt.dk

Your primary tasks will be the following


• Responsible for inspections by authorities and customer audits
• Communication with authorities and customers including change information
• Responsible for new DMF (Drug Master Files) and registration for new countries and maintaining existing DMF and documentation
• Internal and external Audits
• Keeping the company updated accordingly with new regulatory affairs for API manufacturing.
• Making new QAA (Quality Assurance Agreement)
• QA approval of qualification & Validation protocols and reports.
• QA approvals of change controls (fx. Packaging, analytical equipment and methods)
• QA release of GMP related products
• Maintaining the Validation Master Plan, Stie Master File, GMP and CEP certificate for the pharmaceutical salt
• QA routine jobs
• Customer contact regarding quality agreements, statements etc. For Pharma salt
• Facilitate qualification and validation processes
• Education and training of employees

Qualifications


I order to be successful in the job we imagine that you have an educational background as either a pharmacist, an engineer within chemistry or a similar education. You are skilled within regulatory affairs and is used to work with tasks that are complex and were your collaborative skills is needed.
Furthermore, you have experience with GMP and Quality system. You are used to handle customers/suppliers and therefore your English skills both written and orally are great.

Apply for this position:
Please upload your CV and application in English.

Randstad is responsible for the recruitment process for further information please contact Chief Consultant Anne Christine Møller on +45 4024 5185

About Randstad:
Randstad is part of the international Randstad Group, which is the world's second-largest provider of HR solutions. Every day, Randstad finds jobs for more than 550,000 people worldwide. We maintain offices in 39 countries and are represented in Europe, North and South America and Asia. With 20 branches and in-house locations spread across the entire country we are among Denmark's leading temporary staff and recruitment agency, a position we have achieved as a result of our labour market expertise and our ability to match qualified candidates with unique job opportunities.