Quality Assurance Specialist

Quality Assurance Specialist
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Quality Assurance Specialist

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
10/9/2024
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About the role

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
  • Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
  • Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
  • Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
  • Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
  • Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
  • Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
  • Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
  • Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
  • 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
  • Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
  • Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
  • Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
  • Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
  • Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
  • Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
  • Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
  • Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
  • Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
  • 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 Biotechnology, Pharmaceutical or related field
  • 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
  • Experience with product and raw material release processes and related documentation
  • Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
  • Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
  • Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
  • Strong attention to detail and ability to work in a fast-paced, regulated environment
  • Excellent communication and collaboration skills to work with cross-functional teams
  • Good communication and problem-solving skills

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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Quality Assurance 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
  • Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
  • Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
  • Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
  • Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
  • Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
  • Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
  • Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
  • Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
  • Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
  • 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 Biotechnology, Pharmaceutical or related field
  • 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
  • Experience with product and raw material release processes and related documentation
  • Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
  • Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
  • Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
  • Strong attention to detail and ability to work in a fast-paced, regulated environment
  • Excellent communication and collaboration skills to work with cross-functional teams
  • Good communication and problem-solving skills
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)