QMS Site Training Coordinator

1. Position Summary

The Site Training Executive shall be responsible for establishing, managing, and continuously improving the sites Training Program in alignment with GMP, regulatory guidelines (USFDA, MHRA, EMA, WHO), and corporate requirements. The role ensures that all personnel are trained, qualified, and competent to perform their job responsibilities, thereby supporting compliance and inspection readiness.

2. Key Responsibilities

A. Training Program Management

• Develop, implement, and maintain the Site Training System in compliance with cGMP and regulatory expectations.
• Establish training matrices for all departments and ensure role-based competency mapping.
• Oversee periodic GMP training for new and existing employees.

B. Compliance & Documentation

• Ensure training records are complete, accurate, and auditready in Emtims or manual systems.
• Maintain training SOPs and ensure periodic review.
• Ensure compliance with Data Integrity principles (ALCOA/ALCOA+).

C. Training Delivery & Facilitation

• Conduct and coordinate trainings on GMP, GDP, qualification, hygiene, safety, and technical skills.
• Organize refresher programs, workshops, and capability-building sessions.
• Train-the-Trainer (TtT): Develop internal trainers and subject matter experts.

D. Training Effectiveness

• Implement training effectiveness assessments (TEA/TEI) through tests, practical demonstrations, and audits.
• Monitor training KPIs such as training completion rate, overdue training, and competency scores.
• Implement improvements based on metrics, audit findings, and gap assessments.

E. Audit & Regulatory Support

• Act as the site SME for the Training System during internal/external audits.
• Prepare and present training compliance data for regulatory inspections.
• Address audit observations related to training and drive CAPA implementation.

F. CrossFunctional Collaboration

• Coordinate with Production, QC, Engineering, HR, and EH&S for functional training needs.
• Support validation, new equipment introduction, and process changes by ensuring timely training to relevant teams.

G. EmTIMS Oversight

• Manage electronic learning platforms (EmTIMs).
• Prepare training curricula, online modules, and quizzes.
• Troubleshoot LMS issues and support endusers.

3. Qualifications & Experience

Minimum Education

• Bachelors/Master’s degree in Pharmacy, Science, Biotechnology, or related discipline.

Experience

• 3–17 years of experience in pharmaceutical manufacturing/QA

4. Skills & Competencies

• Strong knowledge of cGMP, GDP, and regulatory requirements.
• Excellent communication, facilitation, and presentation skills.
• Strong analytical, planning, and organizational skills.
• Ability to influence crossfunctional teams and manage multiple priorities.
• Problemsolving and continuous improvement mindset.

5. Key Performance Indicators (KPIs)

• Training completion % vs due dates.
• Reduction in overdue training.
• Audit readiness and zero major observations in training system.
• Training effectiveness scores.
• Compliance with training matrix and curricula management.