Quality Assurance Specialist

This role is focused on ensuring the highest standards of quality and compliance within a cutting-edge biopharmaceutical manufacturing environment. You will play a critical part in managing the Quality Management System (QMS), leading supplier qualification processes, and overseeing facility and equipment qualifications. By ensuring compliance with GMP standards and regulatory requirements, you will directly contribute to the success of biopharmaceutical production and product release.
Key Responsibilities: Develop and manage the Quality Management System (QMS), creating and approving SOPs for GMP activities. Oversee facility, utilities, and equipment qualification, including protocol approvals and managing change control records. Lead the supplier qualification program, managing supplier status and approvals. Review technical agreements with suppliers and clients. Perform batch documentation reviews to support product release. Ensure compliance with quality standards, regulatory requirements, and company policies. Requirements: Bachelor's degree in Pharmacy or a scientific discipline. 5+ years of experience in GMP Quality Assurance roles. Strong knowledge of QMS, including deviations, CAPA, and change control. Experience with batch release activities and regulatory audits. Excellent problem-solving, organizational, and communication skills. What's Offered: Professional growth by contributing to the development of a cutting-edge GMP facility. Work with multiple biological products, gaining a unique perspective across their lifecycle. Flexible scheduling based on project needs.