About This Role
This QA Analyst role is responsible for ensuring compliance with regulatory requirements and Good Laboratory Practices (GLP) within the pharmaceutical industry, specifically for analytical laboratory testing and documentation. The position involves preparing and reviewing Standard Operating Procedures (SOPs), managing change controls, deviations, incidents, and Corrective and Preventive Actions (CAPA), and reviewing GLP-related documents to maintain quality standards and regulatory compliance.
Responsibilities
- Prepare, review, and revise Standard Operating Procedures (SOPs) in accordance with applicable regulatory requirements and internal quality standards
- Manage and monitor Change Control procedures to ensure proper evaluation, approval, implementation, and documentation of changes
- Handle deviation management, including investigation, root cause analysis, documentation, and follow-up of corrective actions
- Record, investigate, and document incidents in accordance with established quality procedures
- Initiate, review, and monitor Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues
- Review Good Laboratory Practice (GLP) documents and analytical laboratory records to ensure accuracy, completeness, and compliance
- Ensure compliance with applicable regulatory requirements, quality management systems, and internal laboratory procedures
- Maintain proper documentation and records to support internal audits, regulatory inspections, and quality assessments
- Coordinate with laboratory personnel to ensure adherence to approved procedures and quality standards
- Support continuous improvement initiatives to strengthen documentation practices and maintain a state of regulatory compliance
Requirements
- B.Sc/M.Sc Chemistry
- 1 to 2 years of experience
- Working knowledge of Quality Assurance practices in the pharmaceutical industry
- Knowledge of regulatory requirements applicable to analytical laboratory testing and documentation
- Experience in SOP preparation, review, and revision
- Understanding of Change Control, Deviation Management, Incident Reporting, and CAPA procedures
- Knowledge of GLP documentation review and compliance requirements
- Good documentation, communication, analytical, and problem-solving skills
