Compliance Officer

Key responsibilities

• Facilitate Annual Self Inspection and monitor the closure/effectiveness of every department CAPA
• Address Self Inspection and External audit findings by preparing, implementing and monitoring closure of Corrective and Preventive Actions (CAPA)
• Prepare, review, and update Compliance Unit procedures to comply with local and international regulatory requirements
• Prepare Risk Assessment related to Compliance
• Review and approve controlled documents such as SOPs, batch manufacturing records, validation reports, and deviation reports
• Monitor change control, Deviation Report, CAPA, Non Conformances, and ensure documentation are updated accordingly
• Participate in product complaint, product recall management and investigation processes
• Support validation and qualification activities (equipment, processes, and utilities)
• Conduct compliance and GMP training programs for all personnel
• Collaborate with Production, QC, QA, Engineering, and Warehouse departments to ensure consistent compliance to standards and requirements of the Pharmaceutical Quality System, PIC/S GMP, WHO and Regulatory agency

About you

• Bachelor's Degree in Pharmacy, BS Chem Eng, BS Chemistry, or BS Biology
• Experience in Quality Assurance, FDA Compliance/GMP Compliance, Good Documentation Practices
• Good comprehension and technical writing skills
• Good communication across departments
• Proactive approach