Beschreibung
Task:- 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.
- Ensure training documentation is up-to-date, accurate and retrievable
Requirements (Must have):
- Make recommendations to achieve compliance where shortfalls are found.
- Provide reports as directed.
- Consultancy and guidance of all employees regarding Quality Training
- The person must be analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is desired.
- The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
- The resource should have the ability to travel and be able to work independently ? with minimal supervision
- 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.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Prior experience in medical device / pharmaceutical remediation preferred.
- Proficient in the use of spreadsheet and database software (Access / Excel etc. )
Beginn: 20.10.2014
Dauer: 28.12.2014
Branche: Medizin/Healthcare