Site Compliance GMP Training Manager job in San Carlos
|Employer:|| Novartis Pharmaceuticals|
|Category:||Human Resources - Organizational Development|
|Job Type:||Full Time|
• To ensure all personnel are appropriately trained (and re-trained as required) in accordance with position requirements. |
• Set individual curricula for both mandatory (compliance related) trainings and developmental trainings.
• In conjunction with line units and support functions, develop and maintain training plans aligned to job specifications for new personnel and contractors and ongoing for permanent personnel.
• Take a proactive role for continuous improvement and lead training improvement pro-jects
• Develop the content and format of training materials for the Good Manufacturing Practices training program.
• Responsible for group and individual training sessions, including scheduling, training material/media development, presentation and record keeping.
• Deliver trainings for the key GMP requirements to all levels of personnel across the organization and monitor the quality of training delivery
• Ownership and maintenance of a compliant Training subsystem to support the Site Quality and Development
• Ensure all staff are trained in the principles of GMP
• Develop and provide data on Training KPIs
• Maintain official Manufacturing GMP department training curriculum in centralized location, update and organize on a routine basis with input from supervisors.
• Generate system for tracking Manufacturing GMP training status against current procedures (provide a % trained status update monthly report, maintain training manuals
• Design and deliver a program of routine auditing of departmental training files to verify the local management of individual training files is carried out in a compliant manner.
• Respond to training related audit observations and close out CAPAs in a timely manner.
• Audit training binders.
• Represent the site training systems during audits.
• Provide guidance to and ensure compliance in GMP training practices and documentation.
• Interface with all GMP groups to provide support and oversight of training compliance.
• Deliver select standard corporate training packages
• Support the HR and HSE department in the development, implementation and updates of the training materials and programs.
• Develop training curriculum for employee trainings.Bachelors degree or equivalent experience may be accepted
• A minimum of 5 plus years of training or educational experience
• A minimum of 3 plus years of experience in GXP manufacturing environment (manufacturing or QA)
• Knowledge of an electronic Learning Management System (LMS) is desirable.
• Excellent written, verbal and presentation skills
• Ability to present analysis in a clear and compelling manner
• Ability to work independently with little supervision in day to day tasks
Excellent sense of accountability, team spirit, and result orientation
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