QA Compliance Specialist
International Pharmaceutical Manufacturer requires a QA Compliance Specialist.
About the role:
- Influence and support GxP compliance in all activities performed on site by developing, implementing, maintaining and continuously improving quality standards and systems to ensure that all applicable company operations and processes conform to the principles of GxP
- Lead Annual Product Reviews, Drive Good Distribution Practices, Develop and maintain the Change Management process, Generate / update Certificate of Analysis and customer documents in line with required regulations.
- Analyse/trend data, assess information and generate reports/metrics in order to provide accurate and appropriate responses and to identify potential risks and gaps.
- Provide support to Continuous Improvement Projects where appropriate
Duties may include:
- Build and maintain strong relationships with key business stakeholders and ensure that each department is adhering to the GMP compliance and regulations
- Manage and provide site wide GMP, GDP and Change Control training
- Drive Annual Product Review (APR) Execution
- Coordinate the collation of Annual Product Reviews and Summary Reports
- Management of the current APR process to meet regulatory requirements
- Lead GDP Excursion Monitoring and Rectification
- Review temperature data for product shipments
- Monitor GDP excursions and implement appropriate remediation
- Raise, Investigate, review and Close GDP Incidents
- Host GDP Meetings internally and with Freight Forwarders to rectify identified GDP issues
- Ensure valid Route Risk Assessment approved prior to shipping
- Drive Change Control Management across site
- Coordinate and review Change Control records for accuracy and completion
- Enforce zero overdue Change Control records
- Maintenance and oversight of the TrackWise system to drive closure of overdue/extended records
- Prepare and present metrics (e.g. complaint metrics, change control metrics etc.) to Quality Management on a monthly basis (e.g...... click apply for full job details