William Cook Europe is looking for a versatile Quality Assurance Specialist with a specific interest in GMP compliance for life science products.
Cook is an American-owned company manufacturing medical devices, cell-growth media as well as cell-therapy products for clinical trials. The employee will be part of a small team based in Denmark servicing other Cook companies within the cell-therapy area, e.g., with QP certification and distribution of investigational medicinal products for clinical sites in Europe.
The team works under a manufacturing and importation authorization from the Danish Medicines Agency and in an ISO 9001:2015-certified Quality Management System.
The person we are looking for shall be a team player, meticulous and with strong problem-solving skills and the ability to appreciate both the overall interaction and the specific activities of all processes within the quality management system. You must be able to work both collaboratively and independently with minimal supervision. You will be part of a dedicated team who has an informal and humorous tone and appreciates good workplace relationships.
As a Quality Assurance Specialist, you will be working to ensure that appropriate cGXP documentation is generated, reviewed, approved and maintained and to maintain the Quality Management System.
Your main responsibilities will be:
• Identify and/or assist in the resolution of potential or existing quality issues that may jeopardize patient safety, cGXP compliance or regulatory compliance
• Various quality assurance tasks such as review of quality records including batch records
• Create and update quality system documents such as policies and standard operating procedures
• Participate in risk management activities
• Review and determine the acceptability of nonconformances and corrective and preventive actions
• Perform trend analyses and evaluations
• Perform complaint investigations
• Perform internal auditing
• Assist in the coordination and compliance with requests of regulatory authorities during inspections
• Qualify and monitor suppliers and service providers
• Training of new personnel in both general and specific QA processes
You have an eye for detail and the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. You must be comfortable working independently within your own areas of responsibility, but more importantly, we expect you to be an excellent team player with a positive attitude and committed approach to quality management. You have excellent communication skills at all levels and the desire to work in a global environment.
As a Quality Assurance Specialist, you are expected to have the following qualifications:
• As a minimum, a degree in life science
• Ongoing commitment to upgrading knowledge, job skills and abilities in addition to competences related to all duties and responsibilities
• Excellent and effective English written and oral communication skills
• Experience working in a regulated industry, such as the pharmaceutical or medical device industry
• Preferably, experience with batch review
• Preferably, experience with risk assessment and deviation management
• Preferably, familiarity with EU rules and regulations for advanced-therapy medicinal products
William Cook Europe offers
William Cook Europe’s company culture is based on a set of strong common values where responsible, competent and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humour are highly appreciated.
The team helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - every day, we make a difference.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance and free use of the company’s own gym.
For further information about the position, please contact Susan Agerholm Ballegaard, Manager, Quality Assurance, phone: +45 56 86 86 86 / email: email@example.com.
Please upload your application and CV no later than May 13, 2018.