Description
We are looking for a
GMP Trainer (Industry Medical Devices / Pharmaceuticals) (m/f)
Referenz: -en
Beginn: asap
Dauer: 5 MM+
Ort: in Baden-Württemberg
Branche: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Ihre Aufgaben:
- 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
Ihre Qualifikation
- Analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is desired
- Proficiency in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
- Willingness and ability to travel
- 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.)
- Fluently German / English spoken and written required
- 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
- 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.)
- FDA QSR, ISO 13485
Skills:
- Quality manager