QA Specialist

SmartPractice Hillerød

SmartPractice Denmark develops, manufactures and distributes innovative patch testing medicinal products, ancillary supplies, and world class customer support and education. SmartPractice is the global market leader for contact allergy patch testing, everyday living the motto “because patients deserve a diagnosis”.

SmartPractice’s 45 employees are located in Hillerød and has started the process of building new production facilities and implementing new and optimized equipment for our production.

ABOUT THE POSITION

You will be part of the QA team with currently 5 experienced and highly skilled and motivated colleagues. The QA department is responsible for the quality of all tasks throughout the company and provide support to analytical and pharmaceutical development and production. The QA department is also responsible for securing the right quality of our suppliers who are located all over the world, for release of raw materials, packaging materials for use in the production and release of intermediates and finished products.

As specialist in QA, your responsibilities will range from the early definition of requirements to the final qualification of production line using science and risk-based validation principles.

Your main areas of responsibility will be to:

• Set direction for quality and compliance based on regulatory requirements
• Help set the right requirements for production facilities and equipment
• Approve Qualification/Validation protocols and reports
• Handling QA matters related to manufacturing
• Provide support to production
• Monitor the GMP field with regard to new/amended requirements periodically
• Handle deviations, investigations and change control cases (CCs)
• Evaluate and approve suppliers and contract laboratories world-wide (audits)
• Conduct self-inspections

CANDIDATE PROFILE

As a person you thrive on working with a broad responsibility and managing multiple tasks simultaneously. A great working environment is important to you, and you contribute with drive, positivity and a can-do attitude in order to create passion and job satisfaction around you.

Further, you:

•         hold a Master’s degree in pharmacy, chemical engineering or similar
•          have minimum 5 years’ experience with validation or qualification, preferably as a QA person
•          have excellent skills in collaborating with stakeholders from different organisational levels
•          Have a risk-based approach and the ability to balance compliance and product quality
•          Have a strong quality mindset and result orientation
•          understand and are able to cope with the demands of authorities and other stakeholders

•      are fluent in both Danish and English (orally, written, listening)
•      maintain a good overview, always follow up and meet your deadlines

WORKING AT SMARTPRACTICE
At SmartPractice we offer you an opportunity for a comfortable working environment with room for smiles and with great opportunities for professional and personal development. We make room for different life situations and always put people first, which is why a flexible working environment is given high priority.

APPLICATION

Feel free to call Rikke Esmark Hansen (cell 20 96 95 81) for further information. Candidates are interviewed continuously, therefore please submit your application (written in Danish or English) as soon as possible to rkkl@smartpractice.dk.