Description
Our client is urgently looking for a Quality Training Specialist to support the overall learning and development needs of their sites in Austria and South of Germany.Location: Austria, Germany - regular travel to sites in South Germany
Start: As soon as possible
Duration: End of December 2014
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.
• Make recommendations to achieve compliance where shortfalls are found.
• Provide reports as directed.
• Consultancy and guidance of all employees regarding Quality Training
Knowledge & Skills:
• You must be analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is desired.
• You must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
• You should have the ability to travel and be able to work independently - with minimal supervision
• Be able to work with various databases to extract and report out required information (Excel, Access, SAP etc.).
• Fluently German / English spoken and written required
Competencies:
• Excellent organisational skills, readiness to take on responsibility, reliable, proactive & self-driven, customer oriented
• Be able to manage effectively multiple priorities and tasks.
• Excellent communication skills with all levels for employees
• Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
• Team player
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 spreadsheet and database software (Access / Excel etc.)