Quality Compliance & Training Specialist Role
The Quality Compliance & Training Specialist will work within a small team responsible for Good Manufacturing Practice (GMP) quality compliance and training activities. The role involves implementing, monitoring, maintaining, and improving systems and processes to ensure compliance.
1. Implementing GMP quality compliance systems and processes to meet regulatory standards.
2. Maintenance and administration of training systems and processes to support employee development.
3. Roll out of global initiatives to enhance compliance across the organization.
4. Supporting colleagues with guidance on documentation, compliance issues, and system support to ensure seamless operations.
5. Working proactively to ensure timely delivery of high-quality records, investigations, and associated actions.
6. Monitoring metrics and trends to improve compliance standards and meet internal and external auditor expectations.
7. Leading and supporting quality-based investigations and associated action outcomes, including on-time completion.
8. Providing quality review and oversight of documentation associated with change requests, manufacturing, and cleaning to ensure compliance with global regulatory agencies and industry standards.
9. Developing and continuously improving systems to maintain or enhance compliance within the department.
10. Leading compliance inspections and audits, metric generation, and trending of data.
11. Developing and administering training within the facility to support employee development and compliance.
12. Oversight and support of documentation practices associated with equipment validation and commissioning, SOP management, and training.
13. Assisting colleagues with technical help and guidance on IT compliance and documentation systems.