Qualification-/Validation-Ingenieur


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

29th March 2019

Location

St. Gallen

Salary/Rate

competitive

Salary Notes

competitive

Type

Contract

Start Date

ASAP

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Qualification- / Validation-Ingenieur Job Requirements Formal Education and TrainingDegree in Engineering, Production Technology, MBAOccupational Experience5 Years of experience engineering and qualification of pharmaceutical equipment in a global environment and in interculturalProject teams, thereof at least 3 years with the responsibility for qualification for pharmaceutical equipment. Experience in multiProject management.Additional Knowledge RequirementsStrong qualification capability regarding the cGMP and GAMP guidelines, structured and methodical working style (e.g. FMEA,SWOT, TCO), team-oriented, communicative, highly self-motivated and proactive, result-driven, business fluent command ofEnglish, multi-tasking capabilities, intercultural leadership skills and lean knowledge desired. Major Duties Documentation / QualificationSupports the execution of the equipment qualifications for all global technology projects and process improvementsEnsures that all guidelines (e.g. IMSU, EHS) and as well as all national laws are applied in the projects in case of qualificationSupports the production sites worldwide in case of qualification for equipment's and/or processes if requestedSupports the execution of the process validation if required from internal customers Continous ImprovementSupports the continuous improvement of the qualification process and documents for pharmaceutical equipment regarding the GMP/cGMP guidelinesSupports a professional platform with interaction of Pharmaceutical Systems internal departments as well as other departments (BU, SBF, CS, CF) and third party professionals ProjectsLeads Qualification sub-projects and/or Qualification-work packages for technology projects IMSU / EHS / cGMP / Guidelines for pharmaceutical supplier industryEnsures 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. Corporate Code of Conduct, Labor Safety, Environment Protection and Quality ManagementDeals in compliance with the Corporate Code of ConductEnsures that IMSU and Risk Management guidelines as well as national laws are applied in his area of Responsibility Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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