Validation Specialist
3 settimane fa
Thermo Fisher Scientific is seeking a skilled Technical Documentation Analyst to support our quality team in ensuring the accuracy and completeness of technical documentation.
Key Responsibilities- Technical Documentation Analysis
- Analyze and evaluate technical documentation related to equipment qualification or requalification.
- Acquire all necessary information to develop protocols and implement validation activities.
- Protocol Development
- Develop and maintain technical documentation, including qualification and requalification protocols.
- Collaborate with cross-functional teams to define test procedures and ensure compliance with regulatory requirements.
- Qualification and Validation
- Ensure the qualification and requalification of equipment and systems.
- Perform operational activities as outlined in protocols and coordinate with other functional teams.
- Data Analysis
- Analyze data collected during qualification activities.
- Acquire and document data and results, adhering to Thermo Fisher Scientific's quality management system.
- Qualification Report
- Develop a comprehensive qualification report, detailing analysis and results.
- Ensure report accuracy and completeness, aligning with Thermo Fisher Scientific's quality standards.
- Document Management
- Accurately archive all documentation produced during qualification activities.
- Issue qualification dossiers, ensuring traceability and compliance with regulatory requirements.
- Audit Support
- Support the QA Compliance team in preparing and participating in audits by regulatory bodies or clients.
- Provide necessary information and documentation.
- At least one year of experience in the pharmaceutical industry.
- Proficiency in the English language.
- Bachelor's degree in a scientific field.
- Excellent communication and interpersonal skills.
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Process Validation Specialist
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a highly skilled Process & Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our manufacturing processes and cleaning procedures.Key ResponsibilitiesEvaluate manufacturing process documents and...
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a highly skilled Process & Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our manufacturing processes and cleaning procedures.Key ResponsibilitiesEvaluate and validate manufacturing process...
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a highly skilled Process and Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our organization, you will be responsible for ensuring the validation of manufacturing processes and cleaning procedures to meet regulatory requirements.Key ResponsibilitiesEvaluate and Validate...
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific is seeking a skilled Technical Documentation Analyst to support our quality team in ensuring the accuracy and completeness of technical documentation.Key ResponsibilitiesTechnical Documentation AnalysisAnalyze and evaluate technical documentation related to equipment qualification or requalification.Acquire all necessary...
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific is seeking a skilled Technical Documentation Analyst to support our quality team in ensuring the accuracy and completeness of technical documentation.Key ResponsibilitiesTechnical Documentation AnalysisAnalyze and evaluate technical documentation related to equipment qualification or requalification.Acquire all necessary...
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Ferentino, Italia Thermo Fisher Scientific A tempo pieno: Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes Develop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill) Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification Manage validation protocols for cleaning, process,...
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