Beschreibung
Aufgaben:- Support the overall learning and development needs of the site(s)
- Provide oversight and analysis to managers and supervisors when defining training requirements
- Act as lead facilitator for Global Remediation Quality Plan (GRQP) Training Process roll out
- Work with Managers and Supervisors to build learning plan requirements for all positions / employees
- Collaborate with Quality Training Specialist at other locations to ensure consistency
- Provide leadership and execution for quality systems based training initiatives
- Assist with deployment of all quality related training – including logistical support, data management, scheduling, in classroom assistance, and data entry as needed
- Demonstrate an understanding of the quality training processes and methodology in order to provide learning solutions and ensure personnel are adequately trained to perform their assigned responsibilities
- Primary accountability for facilitating and implementing the qualified instructor program
- Support the Quality Process Managers with the logistics of the defect awareness training
- Perform a review of all training requirements once position descriptions have been updated
- Implement comprehensive training program for cGMP/QSR
Qualifikationen:
- Make recommendations to achieve compliance where shortfalls are found
- Consultancy and guidance of all employees regarding Quality Training
- The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
- Fluently German / English spoken and written required
- Quality / compliance experience in the medical device, pharmaceutical industries or similarly regulated industry
- Documented training in FDA QSR, ISO required
- Prior experience in medical device / pharmaceutical remediation preferred
- FDA QSR, ISO 13485 - MUST HAVE