Marta Ziarkowska

• 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.

• 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.

• 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.