Quality Assurance Engineer

Quality Assurance Engineer
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Quality Assurance Engineer

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
7/29/2024
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About the role

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Ensure manufactured products meet approved company policies, processes and procedures
  • Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
  • Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/ line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out
  • Release incoming material, process and product batches.
  • Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
  • Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies
  • Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
  • Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
  • 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
  • Ensure manufactured products meet approved company policies, processes and procedures
  • Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
  • Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/ line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out
  • Release incoming material, process and product batches.
  • Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
  • Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies
  • Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
  • Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
  • 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 Biomedical Engineering, Biotechnology, Science or equivalent
  • Minimum 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/ or Compliance (GxP) environment
  • Knowledge of quality/ compliance management as well as regulations and standards affecting APIs/ Biologics
  • Ability to quickly know products and processes in order to assess quality issues
  • Experience in SAP, Trackwise
  • 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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Quality Assurance Engineer

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
  • Ensure manufactured products meet approved company policies, processes and procedures
  • Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
  • Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/ line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out
  • Release incoming material, process and product batches.
  • Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
  • Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies
  • Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
  • Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
  • 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 Biomedical Engineering, Biotechnology, Science or equivalent
  • Minimum 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/ or Compliance (GxP) environment
  • Knowledge of quality/ compliance management as well as regulations and standards affecting APIs/ Biologics
  • Ability to quickly know products and processes in order to assess quality issues
  • Experience in SAP, Trackwise
  • 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)