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Senior QA Specialist, Supplier Management. KLIFO is a leading provider of Clinical Trial Supply (CTS) chain services to the international biopharma industry. This is an exciting time to join our company. KLIFO moved our CTS business to a new 6.500 sq. m state-of-the-art facility located near the capital area in Denmark, expanding our team, our capacity and our range of services. To help support our growth, KLIFO is strengthening our Quality Assurance team. Become part of an experienced and dedicated team. KLIFO Quality Assurance helps manage and ensure the correct level of quality and integrity in the CTS and QA services. KLIFO provides you with the unique combination of interesting and challenging tasks related to our own CTS site in Brøndby and Senior QA specialist services for pharmaceutical clients. You will be joining an experienced QA team of 11 highly specialised experts. We take pride in tailoring our solutions to suit each individual client. We provide practical consulting and operational services related to GMP, GDP, GCP, GLP and GVP to ensure that client projects can fulfil the complex regulatory requirements.
Job Responsibility:
Ensuring that our suppliers are in a state of control
Development and maintenance of the Supplier Management Program
Qualification, assessment and evaluation of suppliers
Perform supplier audits
Auditing of a wide variety of project/clients suppliers/manufacturers/vendors
Write up and maintain Quality Agreements for our suppliers
Approval of quality related documents
QA handling of Supplier Complaints
Requirements:
Experience as Lead Auditor
Experience with Supplier Management
+5 years’ experience from the Biopharmaceutical industry or similar
Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API
Relevant academic background within pharmacy, biotechnology or similar
Experience working in both English and Danish, written and spoken
What we offer:
Join an organisation where we value people and their expertise as the greatest asset
Enter a flexible workplace with a culture based on trust, transparency and respect
Work with some of the most experienced and dedicated colleagues in the life-science industry
Contribute with your expertise across different therapeutic areas
Develop tailor-made solutions based on cross-disciplinary collaboration
Cultivate successful relationships with our clients
Be part of an organisation that sees knowledge-sharing as the road to success