Validation Specialist

Validation Specialist
See all offers

Validation Specialist

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
10/28/2024
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About the role

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

Your profile

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

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:

  • Organization and transformation consulting
  • Industrial Engineering
  • Information Systems Management

 

By joining our teams you will discover :

  • A dynamic team in a start-up spirit
  • Human support and career development monitoring
  • Challenges to help develop your network
  • Events: team building, meet-up, workshop, Winter Event ...
  • An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)

APPLY
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Validation Specialist

Asia - Singapore
Industrial Engineering and Life-Science
Permanent

About the role

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

Your profile

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.

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:

  • Organization and transformation consulting
  • Industrial Engineering
  • Information Systems Management

 

By joining our teams you will discover :

  • A dynamic team in a start-up spirit
  • Human support and career development monitoring
  • Challenges to help develop your network
  • Events: team building, meet-up, workshop, Winter Event ...
  • An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)