Training Specialist

For our customer in Solothurn we are looking for a project ASAP for a Quality Training Specialist

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.

Requirements/Experience:

- Bachelor's degree in Education, Management or related field.
- Be able to work with various databases to extract and report out required information (Excel, Access, SAP etc.).
- 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.
- Fluent German/English spoken and written is required, Italian language fluency required for Swiss-Italian site.
- Quality/compliance experience in the medical device, pharmaceutical industries or similarly regulated industry.
- Documented training in FDA QSR, ISO 13485/9001 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. )
- FDA QSR, ISO 13485.

Non-technical requirements:

- Excellent organizational 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.
- Be a team player.

Are you interested in this position? Then we are looking forward to receiving your application.