The Senior QA Specialist will support the effective implementation, monitoring, and maintenance of the quality management system, ensuring the organization complies with GMP and other relevant regulations. You serve as a QA expert, coach, and trainer to colleagues, while addressing quality issues such as deviations and complaints. You ensure timely corrective actions and oversee the creation, review, and approval of SOPs and other QA documents in line with GxP guidelines. Moreover, as Sr. QA Specialist you contribute to risk assessments, validation protocols, QC testing, and batch records to ensure compliance. You assist in compiling documentation for QP disposition, represent the QA department in projects, and advocate for continuous improvement. You support supplier qualifications, inspections, and audits, coordinating CAPAs as needed. Additionally, you conduct internal audits and monitor GMP activities outsourced to third parties. While lastly, you can act as a back-up for the Head of Quality when necessary.