Summary
Provide support in developing and maintaining structured training programs for production personnel and ensuring that they are adequately trained, qualified, and competent to perform assigned tasks in accordance with approved procedures, regulatory requirements, and containment control standards. Assist in the set-up of new production lines and the operationalization of the line. Provide support to HR team in hiring of employees and skills training, and setting up the necessary system infrastructure especially during the initial start-up phase.
Responsibilities
· Assist in developing and maintaining structured training programs for production personnel, including cleanroom behavior, gowning qualification, and aseptic practices, where applicable.
· Conduct initial and periodic refresher training on assigned SOPs, work instructions, contamination control, data integrity, and Good Documentation Practices (GDP).
· Support training for new employees as well as refresher training for existing employees on their roles and responsibility with respect to Good Manufacturing Practices (GMP).
· Coordinate qualification and requalification of operators for identified critical processes.
· Support in production line set-up and the testing of SOPs versus the appropriate and assigned operations.
· Maintain training records and competency matrices in accordance with Document Control procedures.
· Assess training effectiveness through observations, written evaluations, and performance reviews.
· Support investigations where training gaps are identified as potential root causes
· Actively involved in corrective action follow-ups, where and when applicable
· Ensure that only trained and qualified personnel are authorized to perform validated processes
· Ensure compliance with ISO 13485 competency requirements and support sustained process control within ISO Class 7 and ISO Class 8 environments
· Assist HR team in the recruitment of employees for production; screening and interviewing of potential candidates during job interviews
· Support new employee skills and orientation training
Requirements
· Minimum GCE ‘O’ Level education; Those with a professional diploma would have additional advantage
· Relevant GMP clean room and medical device experience
· Excellent communication and presentation skills
· Multi-tasking capabilities and able to work independently and as a team
· Ability to analyze processes and data to determine training needs and develop necessary materials
· Experience in developing instructional materials and conducting training sessions
· Proficiency in Microsoft Office (Word, Excel, Powerpoint)
