QA Officer

Roles & Responsibilities
• Review of Analytical Method Transfer and Analytical Method Validation protocols and reports
• Review of analytical documents related to batch/material testing, process validation, process verification, hold time studies, deblister studies, and cleaning validation
• Review and investigation of Out of Specification (OOS) and Out of Trend (OOT) results
• Review of stability study reports and stability schedules
• Coordinate with QA Manager for timely release of Globalpharma products
• Daily monitoring of GLP compliance in QC laboratories, including microbiology labs
• Review of QC instrument calibration and preventive maintenance reports
• Review of qualification documents for new QC instruments, trend reports, and reduced testing reports
• Review and approval of SOPs, specifications, standard test methods, and product technical specifications
• Issuance, distribution, and retrieval of controlled documents (BMR, BPR, SOPs, specifications, protocols, etc.)
• Preparation and review of QA SOPs
• Ensure compliance and completeness of validation reports
• Creation and management of Change Controls in Caliber
• Preparation and review of Annual Product Quality Review (APQR)
• Assist QA Manager in routine and assigned quality-related activities

Qualification
• Bachelor’s degree in Pharmacy or Science

Experience
• Minimum 5 years of experience in the pharmaceutical industry

Skills
• Strong knowledge of QA/QC documentation, GLP, validation, and compliance systems
• Hands-on experience with QMS tools, Caliber, SAP, and MS Office
• Excellent presentation, documentation, and communication skills in English

About the Organization
Globalpharma Co. LLC is a reputed pharmaceutical manufacturer focused on delivering high-quality, compliant healthcare products. The company emphasizes regulatory excellence, robust quality systems, and continuous professional development for its employees.