Validation Specialist

Validation Specialist
Voir toutes les offres

Validation Specialist

Asia - Singapore
Ingénierie Industrielle et Life-Science
CDI
10/28/2024
POSTULER

Vos responsabilités

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
  • Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
  • Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
  • Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
  • Develop and configure TrackWise workflows and ensure proper documentation.
  • Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
  • Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
  • Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
  • Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
  • Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
  • Develop and configure TrackWise workflows and ensure proper documentation.
  • Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
  • Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Votre profil

This is some text inside of a div block.

Job Requirements:

  • Bachelor’s degree in Computer Science, Life Science, or a related field
  • 1-2 years of experience in validation of computer system in the pharmaceutical industry
  • Proficiency in Kneat, TrackWise, CAPA, and change control processes.
  • Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
  • Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
  • Strong documentation and technical writing skills.
  • Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
  • Excellent communication skills, both written and verbal, in English

À propos d'Antaes

Créée en 2007, Antaes est une société suisse de conseil en management et technologie classée dans le top 15 des sociétés de conseil en Suisse. Nous comptons plus de 300 ingénieurs expérimentés qui partagent notre passion.

 

Présents en Suisse, à Singapour, à Hong-Kong et en France, nous accompagnons nos clients suisses, et internationaux en intervenant dans les domaines suivants :

  • Conseil en organisation et transformation
  • Ingénierie Industrielle
  • Management des systèmes d'Information

 

En rejoignant nos équipes vous découvrirez :

  • Une équipe dynamique dans un esprit start-up
  • Un accompagnement humain et un suivi de l’évolution de votre carrière
  • Des challenges pour contribuer au développement de votre réseau
  • Des événements : team building, meet-up, workshop, Winter Event …
  • Une entreprise certifiée @HappyAtWork et ayant une politique RSE engagée (médaille d’or Ecovadis2023)

POSTULER
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En tant que Chef de projet IT Supply Chain (F/H) , vos missions seront :

 

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En tant que Chargé de Formation Outils Bureautiques H/F vos missions seront :

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Job Description:

  • Contribute to IT topics in the financial industry for Antaes Asia clients
  • Design, develop, and rigorously test new features to support business objectives and improve application functionality.
  • Participate in constructive design discussions to create practical and maintainable solutions
  • Make recommendations on improving and evolving the codebase to enhance performance, scalability, and usability.
  • Provide accurate estimates for development tasks and actively contribute to planning sessions.
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  • Contribute to the promotion of Antaes services on top of assistance provided to clients
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Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Ensures the smooth operation and optimization of the production process while upholding Good Manufacturing Practice (GMP) requirements.
  • Identify opportunities for operational improvements and implement optimization strategies.
  • Assist and guide Standard Users with system-related queries and issues.
  • Collaborate with the production team to ensure the stability of production processes and the execution of operations.
  • Respond to atypical production situations and emergencies, such as process outages, critical alarms, or equipment failures, diagnose issues and take immediate corrective actions or perform manual interventions together with Manufacturing supervisor/delegate, to restore normal operations and prevent any potential safety or quality incidents.
  • Participate in manual intervention remediation projects. Identify, implement, and perform test execution for changes made to the system.
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  • Able to work on holidays and overtime as required. May also be required to adjust work schedule to meet production targets and demands.
  • Any other duties as assigned by supervisor.
  • Contribute to the promotion of Antaes services on top of assistance provided to client.
Voir l'offre
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Validation Specialist

Asia - Singapore
Ingénierie Industrielle et Life-Science
CDI

Vos responsabilités

This is some text inside of a div block.

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
  • Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
  • Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
  • Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
  • Develop and configure TrackWise workflows and ensure proper documentation.
  • Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
  • Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Votre profil

This is some text inside of a div block.

Job Requirements:

  • Bachelor’s degree in Computer Science, Life Science, or a related field
  • 1-2 years of experience in validation of computer system in the pharmaceutical industry
  • Proficiency in Kneat, TrackWise, CAPA, and change control processes.
  • Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
  • Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
  • Strong documentation and technical writing skills.
  • Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
  • Excellent communication skills, both written and verbal, in English
Our positions are open to people who have been recognized as disabled workers. T&S Group promotes diversity and equality in the workplace. All qualified M/F candidates are considered for employment on an equal basis.

À propos d'Antaes

Créée en 2007, Antaes est une société suisse de conseil en management et technologie classée dans le top 15 des sociétés de conseil en Suisse. Nous comptons plus de 300 ingénieurs expérimentés qui partagent notre passion.

 

Présents en Suisse, à Singapour, à Hong-Kong et en France, nous accompagnons nos clients suisses, et internationaux en intervenant dans les domaines suivants :

  • Conseil en organisation et transformation
  • Ingénierie Industrielle
  • Management des systèmes d'Information

 

En rejoignant nos équipes vous découvrirez :

  • Une équipe dynamique dans un esprit start-up
  • Un accompagnement humain et un suivi de l’évolution de votre carrière
  • Des challenges pour contribuer au développement de votre réseau
  • Des événements : team building, meet-up, workshop, Winter Event …
  • Une entreprise certifiée @HappyAtWork et ayant une politique RSE engagée (médaille d’or Ecovadis2023)