Beschreibung
TätigkeitenbeschreibungOur client is a leading international producer of high-quality products within the medical technology industry, representing a highly regarded brand worldwide.
For the construction of a new plant, planned to get productive within the next two years, we ae currently seeking an
Interim Manager QA – Validation Engineer MedTec (f/m)
Responsibilities
Supports the execution of the equipment qualifications for all global technology projects and process
improvements
Ensures that all clients guidelines (e.g. IMSU, EHS) and as well as all national laws are applied in the projects in case of qualification
Supports the production sites worldwide in case of qualification for equipment’s and/or processes if requested
Supports the execution of the process validation if required from internal customers
Supports the continuous improvement of the qualification process and documents for pharmaceutical equipment regarding the GMP / cGMP guidelines
Supports a professional platform with interaction of Pharmaceutical Systems internal departments as well as other client departments and third-party professionals
Leads Qualification sub-projects and/or Qualification-work packages for technology projects
Ensures adherence to and monitoring of legal laws and internal regulations concerning IMSU / EHS / cGMP / Guidelines for pharmaceutical supplier industry / Safety regulations in his/her organization and occasionally involved in the development of new concepts and directives in close cooperation with the IMSU / EHS team and external certified bodies.
Ensures implementation of the concepts in his/her area of responsibility and takes care of the corresponding instruction and training of his/her employees
Requirements
Degree in Engineering, Production Technology, MBA
5 Years of experience engineering and qualification of pharmaceutical equipment in a global environment and in intercultural project teams, thereof at least 3 years with the responsibility for qualification for pharmaceutical equipment.
Experience in multi project management.
Strong qualification capability regarding the cGMP and GAMP guidelines
Structured and methodical working style (e.g. FMEA, SWOT, TCO)
Excellent oral and written communication, negotiation, documentation and cross-functional management skills.
Language skills
Business fluent command of English
German advantageous
Offer
Start: Q1 2019
End: End of 2020
Workload: 100%
Location: Switzerland, South Germany
We offer a very challenging Interim Management position with plenty of room for growth. Sign up over Stefan Ehrlich Head Business Development; by mail / Phone or online registration.
Fähigkeiten (Must have)
Assurance, Audit, cGMP, EHS, GMP, IMSU, Medizin, Medtec, Medtech, Pharma, QA, Qualität, Quality, Validation, Validierung, Zertifizierung