Quality Assurance Specialist Post-Approval Description: The Quality Assurance Specialist, as a member of the QA Post-Approval team, is responsible for completing quality assurance activities effectively and on time. This includes the quality review and approval of executed batch records, creation of Certificates of Packaging/Manufacturing and review of supporting documentation according to customer and regulatory requirements, including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs). The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines. After appropriate training, the post holder is able to complete the tasks described under Responsibilities. Different tasks may have different training requirements and the post holder must be appropriately qualified.
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
