Quality Assurance Officer
Reports to: QA Manager
The Quality Assurance Officer will report to the Quality Assurance Manager on day-to-day issues.
The Quality Assurance Officer will be expected to work within the GMP and safety guidelines set by the company. They will assist the Quality Assurance Manager in ensuring the company Quality Management System (QMS) is maintained and complies with the requirements of Good Manufacturing Practice (GMP) as described in the current EU and ICH guidelines.
The duties/responsibilities include but are not limited to the following:
• Perform QA review of completed batch documentation (batch records, analytical reports/ raw data).
• Co-ordination of the update, issue and reconciliation of SOPs and other controlled procedures.
• Issue of Logbooks for use in analytical and manufacturing
• Issue of batch records to production
• Issue of monographs and proformas to the analytical and solid-state department
• Co-ordination of the Corrective and Preventive Action (CAPA) system
• Logging of audit actions and their completion.
• Generation of the monthly Key Performance Indicator (KPI) data for the Quality Review meetings.
• Perform internal audits and co-ordinate the timely closure of all audit actions.
• Co-ordination of the documentation archival system
• Assist in the preparation and dispatch of customer QA package on completion of project.
• Review of technical reports
• Perform general administration duties.
• Ensure procedures are followed at all times and new issues of Standard Operating Procedures are signed off promptly.
• Demonstrate good safety awareness as described in the Onyx Safety Manual.
• Ensure personal Training Record is signed and updated as applicable and available for review during audits.
• Develop a proactive approach to all aspects of the job, be prepared to take on additional responsibilities as needed.
• Reasonable overtime working as project or management requires.
• Any other reasonable duties required by the Quality Assurance Manager.