Quality Assurance Specialist

Quality Assurance Specialist
See all offers

Quality Assurance Specialist

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
10/9/2024
APPLY

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
Our other offers

Simultaneous Engineering and Design Manager M/F

Switzerland - Geneva
Permanent
Industrial Engineering and Life-Science

We are recruiting a Simultaneous Engineering and Design Manager on a permanent contract to join our industrial expertise division as part of a large-scale, long-term project to expand our partner's activities.

 

As Simultaneous Engineering and Design Manager, your responsibilities will include :

 

  • Organize joint studies between the Design Office and the Methods department to ensure a smooth transition to industrialization.
  • Mobilize the various players in industrialization to harmonize technical requirements with production imperatives.
  • Carry out geometric tolerancing analyses and ensure compliance with Design Office specifications.
  • Communicate any identified need for additional technical expertise to the Business Line Manager.
  • Manage the creation of digital models for production, ensuring their consistency with tolerancing studies.
  • Actively participate in the continuous improvement of a cross-functional standardization approach within the Industrialization function.
See the offer

Industrial Safety Project Manager

France - Haute-savoie
Permanent
Industrial Engineering and Life-Science

We are recruiting an Industrial Safety Project Manager M/F to join our center of expertise on a large-scale, long-term project to expand our partner's activities.

 

As an Industrial Safety Project Manager, your responsibilities will include :

 

  • Manage a new product development project with a strong safety dimension.
  • Ensure compliance with relevant safety standards, including ASPICE and ISO 13849.
  • Coordinate multidisciplinary teams, particularly in software and hardware development.
  • Effectively manage relations and coordination with cross-functional teams located abroad (Italy and Germany).
  • Define and manage project objectives in terms of deadlines, costs and quality.
  • Ensure rigorous monitoring of project progress, identify potential risks and propose appropriate solutions.
See the offer

Industrialization Project Manager, Logistics Equipment Investment F/H

Switzerland - Geneva
Permanent
Industrial Engineering and Life-Science

We are recruiting a Project Manager for Industrialization and Investment in Logistics Equipment to join our center of expertise in a large-scale, long-term project to expand our partner's activities.

 

As Project Manager, your main tasks will be :

 

Industrialization of equipment and acquisition of logistics resources:

 

  • Formulate needs, define objectives and consolidate input data
  • Propose concepts in line with objectives
  • Drawing up specifications
  • Coordinate actions with the project team
  • Supplier selection
  • Lead regular project sessions
  • Drawing up and monitoring schedules
  • Coordinate meetings with industrial partners
  • Suggest areas for continuous improvement and study new logistics technologies
See the offer

C&Q Lead - Fill & Finish

Switzerland - Berne
Permanent
Industrial Engineering and Life-Science
  • Oversee C&Q activities in line with project plans and validation requirements.
  • Lead and coordinate commissioning work for filling and freeze-drying (lyophilization) systems.
  • Manage equipment such as vial filling systems (peristaltic and piston pumps), isolators (Grade A environment), lyophilizers, and stopper treatment stations.
  • Plan and schedule commissioning activities and ensure coordination with other departments.
  • Contribute to updates of the C&Q and validation plans throughout the project.
See the offer

Supply-Chain Project Manager (M/F)

Switzerland - Neuchâtel
Permanent
Industrial Engineering and Life-Science

We are recruiting a Supply-Chain Project Manager (M/F) on a permanent contract to join our industrial expertise division as part of a large-scale, long-term project to expand our partner's activities.

 

As a Supply-Chain Project Manager (M/F), your responsibilities will include :

 

  • Organize and supervise the supply of sub-assemblies and machines needed to manufacture our assembly lines, in accordance with schedules drawn up by Project and Program Managers.

 

  • Facilitate communication between suppliers (subcontractors, internal and external partners) and the various departments. Lead operational and project meetings as required.

 

  • Ensure full understanding and availability of technical documentation from suppliers.

 

  • Ensure that schedules defined by internal and external subcontractors are consistent with those set by Project Managers.

 

  • Ensure regular monitoring of production progress at suppliers, identify and quickly report any deviation from the established schedule, and detect any bottlenecks (raw materials, processes, resources). Communicate this information proactively and follow up on corrective actions taken.

 

  • Identify any technical or quality problems encountered by suppliers, report them to the relevant departments in order to work out solutions, and monitor the implementation of corrective measures at the supplier's.
See the offer
APPLICATION FORM
* required fields
By submitting this form, you acknowledge that you have read our website's privacy policy, which includes your rights regarding your personal data.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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)