QA - Senior Compliance Specialist
Ameria, Alexandriaposted 1 month agoJob Details
Skills And Tools:
Job 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.
Job 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.
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