SIGMA pharmaceutical industries
|Compliance Specialist
Quesna, Menoufia, Egypt
Summary
Manages comprehensive compliance operations within a pharmaceutical manufacturing environment, ensuring adherence to quality and regulatory standards.
Highlights
Managed and closed multiple deviations on time, ensuring proper root cause analysis and effective CAPA implementation to maintain regulatory compliance and operational continuity.
Participated actively in internal and external audits, identifying critical gaps and implementing corrective actions to significantly improve GMP compliance across departments.
Conducted rigorous risk assessments using QRM tools like FMEA, proactively identifying potential issues and mitigating operational risks to enhance product safety and quality.
Streamlined CAPA tracking and follow-up processes, achieving timely closure and enhancing overall effectiveness of corrective actions by ensuring accountability.
Supported and facilitated change control processes, ensuring smooth implementation with minimal disruption to product quality and regulatory compliance.
Effectively handled customer complaints and investigations, ensuring timely resolution and thorough documentation to uphold product integrity and customer satisfaction.
Coordinated and supported product recall activities, ensuring meticulous documentation and adherence to regulatory requirements, minimizing brand impact.
Ensured strict adherence to Good Documentation Practices (GDP) and Data Integrity (ALCOA+) standards, maintaining robust compliance across all operational records.