The QA (Quality Assurance) Officer is responsible for ensuring that the company’s quality management system (QMS) is properly implemented and maintained in line with relevant regulatory requirements, standard operating procedures (SOPs), and industry best practices. The role includes the monitoring and auditing of processes, reviewing documentation, and ensuring compliance with Good Distribution Practices (GDP), and any other applicable standards.
Key Responsibilities:
- Quality Management System (QMS):
- Assist in maintaining and updating the company’s QMS.
- Ensure the correct implementation of standard operating procedures (SOPs).
- Review and update quality documentation as required to meet regulatory standards.
- Compliance:
- Ensure compliance with GDP, GMP, and other regulatory requirements.
- Conduct internal audits and inspections to verify compliance with SOPs, quality standards, and regulations.
- Assist in preparing for external audits from regulatory authorities and customers.
- Document Control:
- Maintain and control quality documents such as procedures, forms, and records.
- Ensure timely review, approval, and distribution of documents.
- Maintain logs for various quality-related activities (e.g., deviations, CAPAs, complaints, audits).
- Deviation and CAPA Management:
- Investigate deviations and quality incidents.
- Recommend corrective and preventive actions (CAPAs) and monitor their implementation.
- Document all findings and ensure CAPAs are effectively closed out within defined timelines.
- Training:
- Assist in training staff on quality-related procedures and regulatory requirements.
- Ensure training records are properly maintained and up to date.
- Customer Complaints:
- Handle customer complaints related to product quality.
- Coordinate investigations and report findings to relevant parties.
- Ensure corrective actions are implemented based on complaint investigations.
- Product Release:
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- Assist in the quality review of batch documentation for the release of medicinal products.
- Ensure products meet all specifications before release for distribution.
- Change Control:
- Monitor and assess changes in processes, equipment, or products that could impact quality.
- Ensure changes are properly evaluated, approved, and documented.
- Environmental Monitoring:
- Monitor and ensure compliance with environmental control procedures (e.g., temperature, humidity, etc.).
- Ensure calibration of monitoring devices is maintained.
- Risk Management:
- Participate in risk assessments to identify potential quality issues and implement mitigation measures.
- Ensure ongoing monitoring of critical processes to identify risks to product quality.
