Senior Validation Expert (m/f)

REFERENZNUMMER:

344659/24

IHRE AUFGABEN:

-Monitor the impact of changing regulations on submission strategies
-Direct communication with regulatory authorities regarding company’s regulatory filings
-Gathering, reviewing and loading user and functional requirements into HPQC
-Guidance to the project team regarding authoring of scripts in accordance with client corporate validation procedures (including script reviews and some possible authoring)
-Overseeing execution of testing and reviewing of testing results and deviations
-Assist the Senior Consultant in Validation procedures
-Lead efforts around innovative solutions to address complex problems around Quality validation projects and life cycle management
-Review/approve change controls and associated validation/testing documentation
-Develop validation test scripts, validation protocols, quality plans and final summary reports as required
-Provide training to system users and IT personnel as required. This training may include SDLC policies and related procedures in addition to use of specific software applications.
-Conduct periodic computer system reviews in accordance with corporate procedures to verify systems remain in compliance and within a validated state
-Create appropriate project plans and work schedules to meet business objectives and priorities.
-Provide an ongoing assessment and management of project risks and determine actions necessary to mitigate risks

IHRE QUALIFIKATIONEN:

-Experience in working in a FDA or ISO regulated environment preferred
-Experienced in leading validation projects (SME with ECM) in the global regulatory affairs area/regulatory submissions
-Exceptional computer skills
-Formal project management training and/or certification a plus
-Prior computer system validation experience
-Strong technical background – familiar with writing queries
-Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practices
-Knowledge in cGMP, GDP, GAMP, 21CFR Part11 and industry best practices
-Validation experience with computerized systems in the pharmaceutical industry
-Exceptional organizational, problem-solving and test script writing skills
-Excellent verbal and written communication skills
-Ability to research issues and determine root causes

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist, Software developer