Quality Systems Training Specialist
SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing Organization (CDMO) with facilities in Korea, US, France, and Ireland.
We specialize in the development, scale-up, and commercial manufacture of APIs, HPAPIs, and Chemical Intermediates. The Swords Campus has been a leader in this field for almost 60 years, producing some of the world's most important medicines.
The Quality Team seeks a permanent Quality Systems Training Specialist to support day-to-day training administration and process improvement projects.
Key Responsibilities:
* LMS Management: Oversee SAP SuccessFactors Learning Management System (LMS), ensuring smooth operations, implementing process improvements, and regularly updating Standard Operating Procedures (SOPs) and training requirements.
* Data Analysis & Reporting: Create and distribute reports on Training Needs Analysis, Training History, and ad-hoc reports, analyzing data to identify trends and gaps.
* Compliance: Ensure training records comply with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), FDA, and other regulations, preparing audit documentation.
* Record Management: Maintain training records in LMS, updating SOPs and training materials.
* Stakeholder Engagement: Collaborate with stakeholders to optimize LMS usage and provide support.
* Time Management: Efficiently manage multiple tasks and deadlines, implementing process improvements.
* Problem-Solving: Resolve LMS-related issues, conducting root cause analysis for recurring problems.
* Communication & Collaboration: Communicate training requirements and updates, organizing external training courses.
* Continuous Improvement: Stay updated on LMS best practices and industry standards to enhance training programs.
Required Competencies:
* Proficiency in LMS platforms, particularly SAP SuccessFactors LMS.
* Familiarity with GMP, GDP, FDA regulations.
* Attention to detail in maintaining training records.
* Efficient time management for multiple tasks.
* Proficiency in document management for SOPs and assessments.
* Ability to work closely with stakeholders for LMS optimization.
About Us:
* Work with a world leader in CDMO.
* Opportunities for career and personal development.
* Competitive base salary with annual bonus.
* Further education program.
* Pension scheme.
* Private health insurance.