Description
We are looking for a
Senior Validation Expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Hesse
Branch: Erbringung von sonstigen Dienstleistungen der Informationstechnologie
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Qualification/validation specialist
- Software developer