Beschreibung
Quality Training Specialist
Various positions: Switzerland, Germany & Austria
CHF 110
3-6 months
Our client, a globally recognised giant in their field, is seeking a Quality Regulatory Consultant to join their team on site across Switzerland, Germany & Austria assisting with their quality process and the regulations surrounding current procedures and improvements. Ideally the desired professionals will have experience working as a Quality Systems Trainers in a Pharmaceutical/Medical Devices environment and hold a keen eye for accuracy and dedication for driving business forward.
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
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
Required degree/certificates:
* Bachelor's degree in Education, Management or related field.
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, Italian language fluency required for Mezzovico site.
Competencies:
* 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.
* 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)
Please send your CV or call