Computerized System Validation Coordinator
hace 2 meses
Overview:
Ensure that GxP critical electronic systems meet regulatory standards, maintain data integrity, and contribute to the overall quality and compliance objectives of the organization.
**Responsibilities**:
- **Validation Strategy**: Develop and implement a validation strategy for electronic systems, ensuring compliance with industry regulations and company standards. This includes defining validation requirements, protocols, and procedures.
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Documentation and Compliance**: Prepare and maintain validation documentation, including validation plans, test scripts, and validation reports. Ensure compliance with regulatory requirements, such as Good Practices (GxP) and other relevant guidelines.
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Risk Assessment and Mitigation**: Identify potential risks associated with electronic systems and develop risk mitigation strategies. Conduct risk assessments, implement risk controls, and monitor ongoing compliance to minimize the impact of risks on pharmaceutical operations.
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Change Control and Continuous Improvement**: Manage the change control process for electronic systems, assessing the impact of changes on quality and compliance. Implement continuous improvement initiatives to enhance the validation process, streamline procedures, and adopt emerging technologies.
Qualifications:
- **Knowledge of Pharma Industry and Quality Assurance**: A strong understanding of the pharmaceutical industry, its regulatory environment, and quality assurance processes is crucial. Familiarity with pharmaceutical industry GxP standards (such as EudraLex Vol.4 Annex 11 and Annex 15), CFR regulations (such as 21CFR Part 11) and GAMP5.
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Validation Expertise**: Proficiency in electronic system validation methodologies, including knowledge of validation strategies, protocols, and procedures. Experience in creating and executing test plans, conducting validation testing, and documenting results.
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Quality and Compliance Mindset**: Strong attention to detail and commitment to maintaining quality and compliance standards. Ability to assess risks, identify gaps, and implement appropriate controls to ensure compliance with regulatory requirements.
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Communication and Collaboration**: Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams, including IT professionals, quality assurance personnel, and regulatory authorities. Ability to clearly convey validation requirements, results, and recommendations.
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Analytical and Problem-Solving Abilities**: Strong analytical thinking and problem-solving skills to identify and address validation issues, deviations, and non-compliance situations. Capacity to propose and implement solutions to improve validation processes and mitigate risks.
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Documentation and Reporting**: Proficiency in documenting validation activities, including creating validation plans, protocols, and reports. Ability to effectively communicate findings, deviations, and corrective actions in a clear and concise manner.
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Qualification and Education**: A bachelor's or master's degree in a relevant field such as Computer Science, Information Technology, or a related discipline is required. Professional certifications in electronic system validation can be advantageous.
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Languages**:Fluent Spanish and English, knowledge of other languages will be an asset.
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Experience (years/area)**: +3 years of experience in similar positions in Pharma sector with experience at international level. Proven experience in quality assurance + 3 years.
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