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Validation Engineer (Test Method Validation) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Engineer, Support
Projektbeschreibung
REFERENZNUMMER:
325683/11
IHRE AUFGABEN:
-Originate test method assessment, including protocol and plan for outlined CCPs or other control points
-Coordinate required actions and assure that test method validations are completed on time
-Origination and approval of TMV, including determination of sample size and worst case parts
-Draft and review job breakdown sheets, including conduction of 4-Step Method training
-Establish adequate documentation for CAPA action; Conduct transfers of TMV protocols and plans
-Originate requested documents for validation and computer system validation with support of subject matter experts
IHRE QUALIFIKATIONEN:
-Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification) with a broad technical/educational skills base
-Knowledge of bespoke validation and processes
-Ability to write technical documentation (work instructions, risk assessment and plan etc.)
-In-depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry desirable
-High understanding of GMP, compliance, validation practices, including the system development life cycle and Regulatory expectations
-Working experience with regard to validation computer systems for use in a FDA regulated environment, fluency in English and German
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
325683/11
IHRE AUFGABEN:
-Originate test method assessment, including protocol and plan for outlined CCPs or other control points
-Coordinate required actions and assure that test method validations are completed on time
-Origination and approval of TMV, including determination of sample size and worst case parts
-Draft and review job breakdown sheets, including conduction of 4-Step Method training
-Establish adequate documentation for CAPA action; Conduct transfers of TMV protocols and plans
-Originate requested documents for validation and computer system validation with support of subject matter experts
IHRE QUALIFIKATIONEN:
-Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification) with a broad technical/educational skills base
-Knowledge of bespoke validation and processes
-Ability to write technical documentation (work instructions, risk assessment and plan etc.)
-In-depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry desirable
-High understanding of GMP, compliance, validation practices, including the system development life cycle and Regulatory expectations
-Working experience with regard to validation computer systems for use in a FDA regulated environment, fluency in English and German
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges