✨ AI Summary
The Senior Compliance Specialist will support site readiness for regulatory and internal audits and inspections within the pharmaceutical industry. Key responsibilities include managing and following up on Deviations, CAPAs, Complaints, Recalls, and audit findings. The role involves conducting internal audits and self-inspections, monitoring compliance with cGMP, GDP, and internal procedures, and identifying improvement opportunities. The specialist will also support supplier qualification activities and ensure compliance of sterile manufacturing activities. Collaboration with cross-functional teams to resolve compliance issues and maintain a strong quality culture is essential. The ideal candidate possesses a Bachelor's degree in Pharmacy or Science, 3-5 years of QA experience in pharmaceuticals, and strong knowledge of cGMP, GDP, and pharmaceutical quality systems. Proficiency in audits, inspections, Deviations, and CAPA is required, with a preference for knowledge of sterile manufacturing and contamination control.
Requirements
Bachelor's degree in Pharmacy, Science, or a related field.3–5 years of relevant QA experience in the pharmaceutical industry.Strong knowledge of cGMP, GDP, and pharmaceutical quality systems.Experience in audits, inspections, Deviations, CAPA, and compliance activities.Knowledge of sterile manufacturing and contamination control is preferred.Strong analytical, communication, problem-solving, and organizational skills.Good command of English.
Description
Support site readiness for regulatory and internal audits and inspections.Manage and follow up on Deviations, CAPAs, Complaints, Recalls, and audit findings.Conduct internal audits and self-inspections and support timely closure of observations.Monitor compliance with cGMP, GDP, and internal procedures and identify improvement opportunities.Support supplier and service provider qualification activities.Ensure compliance of sterile manufacturing activities, where applicable.Prepare and maintain quality and compliance documentation and reports.Collaborate with cross-functional teams to resolve compliance issues and maintain a strong quality culture.