Senior Quality Assurance Officer

About the role

The Senior Quality Assurance Officer will support the quality system processes at MSPharma, ensuring compliance with GMPs and company SOPs. This role involves auditing production records, guiding plant operations, and coordinating with cross‑functional teams to maintain high quality standards.

Key responsibilities

• Audit and review production batch records before and after each production stage for GMP compliance.
• Provide guidance on machine capacity, operation, and environmental parameters (pressure, temperature, humidity).
• Coordinate CAPA, OOS, deviations, non‑conformance investigations and log deviations under supervision.
• Work with Maintenance on preventive and corrective maintenance activities.
• Assist in failure investigations, SOP revisions, and documentation control.
• Maintain records for material destruction and ensure proper archiving.
• Train new staff on system changes and prepare QA activity summaries.
• Collaborate with Regulatory Affairs on product registration and shelf‑life issues.
• Interface with Quality Control and Microbiology departments for analytical testing coordination.

Required profile

• Minimum 24 months of experience in quality assurance within a GMP‑regulated environment.
• Familiarity with pharmaceutical production processes and regulatory requirements.

Required skills

• Trend Analysis
• FDA regulations
• MOH guidelines
• GMP compliance
• Production Area Layout Design
• GLP practices
• ICH guidelines
• Systems Development and Workflow
• Good Documentation Practices
• ISPE Guidelines
• Documentation Control Systems
• Failure Investigations
• EMA regulations
• WHO standards
• Tracking Systems
• Statistical Analysis