✨ AI Summary
The QA Professional Compliance Officer will ensure compliance with GMP, GDP, and local regulatory requirements, and monitor the implementation of the Quality Management System (QMS). Responsibilities include reviewing SOPs, overseeing Deviations, CAPA, Change Controls, and Risk Assessments, reviewing investigation reports, and ensuring effective CAPA closure. The role also involves monitoring Data Integrity compliance, leading internal and supplier audits, coordinating responses to regulatory findings, and analyzing compliance trends to recommend preventive strategies.
Requirements
Bachelor's degree in Pharmacy, Science, or related field.4-6 years of experience in QA or Compliance within pharmaceutical industry.Strong knowledge of GMP, GDP, QMS, and regulatory requirements.Experience in handling audits and inspections,High attention to detail and strong organizational skills.Strong investigation, analytical, and leadership skills.Excellent documentation and communication abilities.High level of integrity and decision-making capability
Description
Ensure compliance with GMP, GDP, and local regulatory requirements. Monitor implementation of Quality Management System (QMS).Review SOPs and ensure they are updated according to regulatory standards.Oversee management of Deviations, CAPA, Change Controls, and Risk Assessments.Review and approve investigation reports and root cause analyses.Ensure effective implementation and closure of CAPAs.Monitor Data Integrity compliance (ALCOA++ principles).Lead internal audits and participate in supplier audits.Coordinate and manage responses to regulatory inspection findings.Analyze compliance trends and recommend preventive strategies