Quality and Validation Consultant (m/f)

REFERENZNUMMER:

330312/11

IHRE AUFGABEN:

-Serve as technical expert for the validation process and responsibilities to ensure compliance
-Suggest and sometimes implement innovation and continuous improvement within the validation process
-Implement initiatives in the validation process that will deliver customer value at lowest cost
-Update/compile process validation documents (Engineering Studies, IQ, OQ, PQ) and execute/follow these validations
-Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
-Continuous learning/managing risks; ensure compliance through assisting in audits
-Update/compile URS (User Requirement Specifications) for the machine and modules of it

IHRE QUALIFIKATIONEN:

-Profound knowledge of bespoke validation as well as process knowledge and documentation
-In-depth knowledge of European regulations associated with the medical device industry
-High understanding of GMP, compliance, validation practices, including the system development life cycle and regulatory expectations
-Working experience of validation computer systems for use in a FDA regulated environment
-Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification) with a broad technical/educational skills base
-Experience of working in a regulated environment, including carrying out validation and/or testing activities
-Fluency in English and German

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist