Marta Ziarkowska
IT Validation Lead
Talent
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.
