Święta Katarzyna, Powiat wrocławski0Członek od 16 lipca 2025
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O mnie
CS IT Validation knowledge within pharma industry (Agile and Waterfall methodologies),
Strong knowledge of GxP (Good Practices) – critical thinking, risk management and identification, quality processes,
Knowledge of industry standards and guidelines for the pharmaceutical industry (experience with FDA inspection),
Experience with large-scale projects (projects related to: clinical documentation management, reporting of adverse events or DevOps), experience with Business Critical projects,
Very good cooperation with stakeholders,
Implements quality procedures for the development and operation of computerized systems,
Review/approve risk assessments and control activities,
Support lifecycle processes (implementation, maintenance, retirement phases),
Provides counselling and training related to CSV,
Preparation of protocols and validation reports,
Good knowledge of Microsoft Office and Google Workspace,
Effective work both in a group and alone,
Accuracy and precision,
Diligence and responsibility.
Doświadczenie
CS IT Validation knowledge within pharma industry (Agile and Waterfall methodologies),
Strong knowledge of GxP (Good Practices) – critical thinking, risk management and identification, quality processes,
Knowledge of industry standards and guidelines for the pharmaceutical industry (experience with FDA inspection),
Experience with large-scale projects (projects related to: clinical documentation management, reporting of adverse events or DevOps), experience with Business Critical projects,
Very good cooperation with stakeholders,
Implements quality procedures for the development and operation of computerized systems,
Review/approve risk assessments and control activities,
Support lifecycle processes (implementation, maintenance, retirement phases),
Provides counselling and training related to CSV,
Preparation of protocols and validation reports,
Good knowledge of Microsoft Office and Google Workspace,
Effective work both in a group and alone,
Accuracy and precision,
Diligence and responsibility.
Wykształcenie
Implements quality procedures for the development and operation of computerised systems
Reviews/Approves risk assessment and control activities
Supports project phase activities as defined in computerised system validation plans
Supports lifecycle processes such as change control and document management
Provides counselling and training related to computerised systems quality and compliance
Provides overall oversight on System Lifecycle documents and triggers document update, when necessary
Communication with leaders to update on status of activities.
Opinie
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