Ensure the training system is complying, according to the provisions of the regulation (CFR 820). Responsible in the creation, management, and identification of the needs in the regulatory training department. Responsible in the administration of all curriculums in the company; in order, for the employees to acquire the appropriate preparation and skills that will allow them to achieve the highest quality performance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Ensure that employees returning from an excused absence are properly reintegrated and trained before starting their job duties.
• Follow-up with all departments to ensure they maintain zero overdue.
• Ensure that employees returning from leave of absence are trained in all the requirements in his or her training profile.
• Make reports and notify the appropriate areas of the training status.
• Participate periodic monitoring in the areas of production to ensure that all systems are in line (system vs. plant).
• Input all training records.
• File all documentation generated by training department and Keep up to date all folders in the area.
• Approve documents and/or procedures in the NWQS/Windchill system.
• Keep the Compliance Wire System up to date: input new employee information, activation, and deactivation of employees, creating training profile, etc.
• Keep updated user groups, assigning training profile to the newly promoted employees, transfer of employees and temporary assignments in Training System.
• Responsible for providing evidence required by the different areas, such as Compliance Wire system reports and/or physical documents.
• Other related activities in the position.
• Knowledgeable in FDA, Good Documentation Practices, JPAL, QSR, ISO 13485, company global policies and site specific procedures.
• Skilled in handling of internal and external audits.
• Fluent in English.
• Able to use word processor and spreadsheet to evaluate data, trends and system configuration. Skilled in people management.
EDUCATION & EXPERIENCE REQUIREMENTS
• Bachelor Degree
• Minimum of 1 year of experience, preferably in regulated industry.
• Experienced in ERP
• One to three years experiences in Training capacity.
• Or an equivalent combination of education, training or experience.
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