Senior Technical Trainer

Job Description Summary

The Technical & GMP Trainer role exists to provide technical and GMP training proficiency and consultative guidance as a business partner to assigned Asset and/or Functional group. This position is passionate about training & committed to excellence while ensuring employees are properly trained prior to performance. Collaborates with supported Asset and/or Functional group to ensure business objectives are met through effective learning and training solutions. Applies adult learning and instructional design in the development and delivery of training modules in specialized technical and GMP topics. The role is the Asset and/or Functional Group POC (Point of Contact) for audit response, representing Technical & GMP Training during audits and inspections, or other emergent issues, consulting on curriculum development for new or modified roles, and leading strategic training projects. The Technical & GMP trainer is a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture.

Job Description

Develops an ongoing Asset GMP Training Plan to define program deliverables, including justification for topics, measures of effectiveness to be used and an annual summary report.

Conducts needs assessment and performance analysis to determine GMP training needs (e.g. evaluation of Quality events, CAPAs, internal or external audit observations).

Executes Root Cause Analysis and corrective actions where a training solution is identified.

Builds assessments and evaluations to measure progress and to evaluate effectiveness of the Asset / Functional group GMP training programs.

Establishes and maintains metrics to measure the effectiveness of training and report to management.

In collaboration with subject matter expert(s) and Technical & GMP Training Instructional Designer, develops training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience (e.g. videos, computer based training, wiki, websites, LQMs, trainee and trainer manuals, job aids, etc.), including the necessary storyboards, outlines, and project plans.

Leverages knowledge of business and customers in order to identify SMEs and potential departmental trainers.

Facilitates Train The Trainer sessions

Consults with the Technical and GMP Training Back Office and reports issues impacting the quality, compliance and effectiveness of the Learning Management System (LMS).

Performs other duties as assigned.

We expect

Bachelor Degree or above, preferred Biologics background

Fluent in Chinese and English, both oral and written

1-3 years related working experience

GMP Knowhow

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