Beschreibung
German Speaking Quality Training Specialist - Medical Devices/Pharmaceutical - Germany, Austria or Switzerland
Urgent requirement with an ASAP start
- Knowledge & Skills:
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
- Specific technical skills (please detail):
Be able to work with various databases to extract and report out required information (Excel, Access, SAP etc.).
- Specific languages:
Fluently German/English spoken and written required.
- Experience:
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 spread sheets and database software (Access/Excel etc. )
- Unique Selling Points:
FDA QSR, ISO 13485
Overall Responsibilities:
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.
- Job description/Functional experience requirements:
Make recommendations to achieve compliance where shortfalls are found.
Provide reports as directed.
Consultancy and guidance of all employees regarding Quality Training