Brief Summary
Join a dynamic team as a Quality Assurance Specialist, where you will play a pivotal role in ensuring compliance with industry standards and driving quality improvement initiatives. Responsibilities
Ensure adherence to GxP, GMP, ISO, and regulatory requirements. Manage quality systems including CAPA, change control, deviations, and customer/supplier complaints. Conduct and support internal audits, as well as external audits and regulatory inspections. Support qualification and validation activities such as IQ/OQ/PQ and risk assessments. Review batch records and perform material and product release using SAP issue COAs. Maintain SOPs and relevant quality documentation assist with regulatory submissions. Perform root cause analysis and lead continuous quality improvement initiatives. Manage supplier qualification processes and provide training on quality standards. Support various ongoing QA activities, projects, and ad hoc duties as needed. Requirements
Bachelor's...