How you’ll spend your day
Evaluate training needs and participate in the delivery of training materials for the company including Manufacturing, Quality, and Support groups ensuring compliance with the training policy and all training procedures.
Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc.
Maintain a compliant training record keeping (data entry and hard-copy files) system.
Assist in developing curricula of on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approved training content and working with area supervision, manages assignments within the Learning Management System (LMS)
Prepare training completion metrics for dissemination at Quality Review Board meetings.
Work with area managers to determine training frequency/re-training intervals based on roles and responsibilities.
Assist in developing training assessment tools, such as tests and competency evaluation worksheets.
Review Quality records to ensure conformance to approved procedures and cGMP.
Maintain an annual scheduled training calendar, ensuring on-time delivery of annual GMP training and other GxP trainings.
Act as Single Point of Contact (SPOC) between Corporate Documentation & Training group and site, working towards harmonization of the site training and site procedures with corporate expectations.
Assists in monitoring documentation due for annual periodic review.
Any other task assigned by reporting manager.
Your experience and qualifications
Graduate/Post Graduate/Engineering background
Candidate should have good background in QA and Quality system with 10 to 15 years.
He should have knowledge about GMP system and GMP requirements at site together with knowledge on the Training requirements in Pharma Industry.
Knowledge about TNI, Training Modules, Training of GMP refreshing, Data Integrity. In addition, know about investigation, CAPA management and Change control system
