GMP Trainer (Port Elizabeth) at Aspen Pharma Group

Description

• Oversee GMP related training interventions
• Provide oversight and support of the training system
• Plan for, schedule and report on training
• Develop training material and conduct training and assessments
• Keep records and perform administrative / compliance tasks
• Report on GMP training compliance to line / dept. managers
• Maintain training records and perform administrative tasks to ensure regulatory requirements are met

Requirements

Training administration

• Ensure GMP training plan is developed for plant, in line with operations plan.
• Assist in maintaining GMP training programmes
• Serve as a training system administrator in the LMS.
• Act as process SME, with detailed knowledge of process history, compliance, operations, and changes
• Make proposals on improvements to training systems, policies, and procedures.
• Maintain GMP training data and monitor and reports on Capability performance metrics.
• Ensure SOPs are updated regularly and are available for on-the-job coaching and assessment.
• Present objective data regarding process performance
• Maintain up to date knowledge of industry and regulatory trends, ensuring system remains compliant.

Training

• Design, develop and schedule classroom, eLearning, and skills assessment training, based on user requirements.
• Assess new and existing training material.
• Deliver lectures on GMP topics and industry/ site trends.
• Train Production operators in GMP production activities
• Train QC operators in GMP IPC and QC testing activities
• Train QA operators to facilitate understanding of manufacturing processes.
• Provide feedback to training delegates regarding competency.

Communications

• Liaise with line/ department managers to ensure GMP training requirements are met.
• Assist in disseminating regulatory updates.
• Assist in authoring development reports and regulatory documentation.
• Work with external service providers, as needed, in providing a conduit to disseminate relevant training.

Skills Required

Background/experience

• 6 years' relevant experience
• Pharmaceutical industry experience and/ or e experience working in a laboratory environment.
• Experience with electronic learning management and electronic document management
• Understanding of training procedures and techniques
• National Diploma in Pharmacy/Chemistry/ Biomedical Science or a related discipline