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

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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
Nos autres offres

Senior Tech Transfer Project Manager

Suisse - Vaud
CDI
Ingénierie Industrielle et Life-Science

As a Tech Transfer Project Manager, you will lead international technology transfer projects and act as the key link between global teams and local operations (Brazil). You will ensure smooth execution, clear communication, and alignment across all stakeholders.

 

 

The project :

  • Lead cross-functional, international project teams
  • Act as the main point of contact between global and local stakeholders
  • Plan, coordinate, and monitor all project activities and deliverables
  • Define timelines, track KPIs, and ensure project milestones are met
  • Manage project risks and implement mitigation strategies
  • Organize project meetings and ensure clear communication across teams
  • Support on-site activities and team readiness at the receiving unit
  • Collaborate with departments such as Quality, Supply Chain, Manufacturing, and Procurement
  • Provide regular updates to senior leadership on project progress, risks, and solutions
Voir l'offre

Business Analyst

Asia - Singapore
CDI
Digital et Systèmes d'Information

Position Summary

The role involves contributing to the development, enhancement, and ongoing support of the Calypso Back Office system across both project delivery and business-as-usual activities. It plays a key part in ensuring the stability and efficiency of daily operations.

Success in this role requires a thorough understanding of business processes, operational timelines, and data exchanges between internal platforms and external systems. The team collaborates closely with business stakeholders, architects, infrastructure teams, and system administrators to deliver high-quality solutions.

Core Responsibilities

Project Delivery & Change Management

  • Assess and analyse enhancement requests related to repo activities and new product rollouts.

  • Define and recommend functional and technical solutions in partnership with Solution Architects.

  • Prepare detailed specifications, effort estimations, implementation plans, test cases, and release documentation.

  • Lead and coordinate User Acceptance Testing (UAT).

  • Contribute to monthly production releases, ensuring alignment with development and testing milestones.

  • Support production deployments and maintain alignment with the overall release roadmap.

Incident & Application Support

  • Provide expert-level (L3) support to business users and IT stakeholders.

  • Diagnose, investigate, and resolve production issues and system defects.

Process Optimization & Team Support

  • Drive continuous improvement initiatives to enhance operational efficiency.

  • Provide guidance and mentorship to junior team members as needed.

Voir l'offre

Calypso Developer

Asia - Singapore
CDI
Digital et Systèmes d'Information

Job Description:

- Contribute to IT projects for Antaes clients

Main Responsibilities

  • Build management
  • - Develop in JAVA for Calypso v14.4 package.
  • - Develop internal components.
  • Incidents and Requests management (business users and other IT teams.
  • - Communicate effectively.
  • - Analyse enhancement requests and bug-fixes.
  • - Document deliveries.
  • Change Management
  • - Apply monthly release strategy, following the team’s milestones for analysis, coding and testing.
  • - Support the release roadmap in production.
  • - Operations management
  • - Application support, level 1 and 2
  • - Troubleshoot and fix issues.
  • Continuous Improvement
  • - Process improvements.
  • - Coach more junior team members as required.
  • Research, design, and develop software.
  • Analyse user needs and develop software solutions
  • Update software, enhances existing software capabilities, and develops and direct software testing and validation procedures
  • Work with other engineers to integrate hardware and/or software systems
  • Develop specifications and performance requirements.
Voir l'offre

Junior Business Development Manager

Asia - Singapore
CDI
Digital et Systèmes d'Information

About the Role

Antaes Asia is looking for a driven and entrepreneurial Junior Business Development Manager to support our expansion in Asia. This role combines client acquisition and recruitment, making it ideal for someone who wants to develop a 360° understanding of how a consulting business grows.

You will play a key role in sourcing new clients while also recruiting the right consultants to deliver on project needs—ensuring a strong alignment between business opportunities and talent.

Key Responsibilities

Client Sourcing & Business Development (Core Focus)

  • Identify, target, and acquire new clients across key industries.
  • Develop and manage a pipeline of business opportunities.
  • Conduct outreach (calls, meetings, networking) to generate leads.
  • Understand client challenges and propose tailored consulting solutions.
  • Participate in contract negotiations and closing deals.

Recruitment & Talent Acquisition (Core Focus)

  • Drive end-to-end recruitment activities to support business growth.
  • Source and attract qualified candidates through various channels.
  • Screen, interview, and assess consultants based on client needs.
  • Build and maintain a strong talent pipeline aligned with market demand.
  • Match candidates to client opportunities and manage the placement process.

Account Management

  • Maintain strong relationships with existing clients.
  • Ensure successful delivery by aligning consultants with client expectations.
  • Anticipate future hiring needs and proactively source talent.
  • Support ongoing business development within existing accounts.
Voir l'offre

Senior Business Analyst, Calypso

Asia - Singapore
CDI
Digital et Systèmes d'Information

Context:

  • Capital Market IT applications (in-house and package) used worldwide, covering Front Office (Murex, Apex, Orchestrade…), Back Office (Summit, Calypso…), Market data referential (Asset Control...), Market Risk (in-house application on big data technologies).
  • This role aims to develop on the Calypso back-office package, in project mode as well as maintenance, and to support the “run the bank” function. It requires a deep understanding of the nature of business operations, timing of activities & data flowing through internal and external systems. The build and support team continuously works with business users, infrastructure engineers and system managers.

Job Description:

  • Contribute to IT initiatives for Antaes Asia clients
  • Build & change management
  1. Analyse enhancement requests for the repo business and new products.
  2. Propose solutions in collaboration with Architects.
  3. Specifications, workload estimates, planning, test scenarios, release documentation.
  4. Coordinate user acceptance tests.
  5. Monthly releases, following the team’s milestones for analysis, coding and testing.
  6. Support the release roadmap in production.
  • Incidents and Requests management (business users and other IT teams.
  1. Application support, level 3 (expert).
  2. Troubleshoot and fix issues/bugs.
  • Continuous improvement
  1. Improve operational processes.
  2. Coach more junior team members as required.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients
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)