- FR
Quality System Specialist
Quality System Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
- Ensure compliance with regulatory standards and internal policies for all validation processes
- Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
- Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
- Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
- Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
- Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
- Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
- Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
- Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's Degree in Biomedical Engineering, Biotechnology, Science or equivalent
- 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
- Experience with validation processes and quality oversight, including data integrity
- Strong understanding of cGMP regulations and validation principles
- Experience with risk assessment, gap analysis, and CAPA processes
- Problem-solving ability with a focus on proactive solutions and process improvement
- 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)
Watchmaking Product Industrialization Project Manager F/H
We are recruiting a Watchmaking Product Industrialization Project Manager on a permanent contract to join our Industrial Expertise division as part of a large-scale, long-term project to expand the activities of our partner in Geneva.
As a Watchmaking Product Industrialization Project Manager, your responsibilities will include :
- Plan and lead technical convergence reviews, including process plans, controls and capabilities.
- Develop and industrialize ranges and bills of materials for new products.
- Manage activity planning and risk management.
- Unite the resources involved.
- Manage and implement product and process evolutions, adapting the governance of series during their life cycle.
- Capitalize on best practices and contribute to the development of reference systems.
- Manage the model plan approach in line with industrial tool capacities.
Industrial Project Planner (M/F)
- Ensure global visibility of NP project planning.
- Propose strategies for anticipating and optimizing flows.
- Ensure the updating and evolution of data required for planning purposes.
- Ensure consistency and synchronization of projects with schedules.
- Actively participate in cross-functional projects to improve planning processes.
Product Industrialization Project Manager (M/H)
We are recruiting a Watchmaking Product Industrialization Project Manager on a permanent contract to join our Industrial Expertise division as part of a large-scale, long-term project to expand the activities of our partner in Geneva.
As a Watchmaking Product Industrialization Project Manager, your responsibilities will include :
- Plan and lead technical convergence reviews, including process plans, controls and capabilities.
- Develop and industrialize ranges and bills of materials for new products.
- Manage activity planning and risk management.
- Unite the resources involved.
- Manage and implement product and process evolutions, adapting the governance of series during their life cycle.
- Capitalize on best practices and contribute to the development of reference systems.
- Manage the model plan approach in line with industrial tool capacities.
Automation technician
To join our teams near Freiburg, we are looking for an Automation Engineer with mastery of Beckhoff, Siemens, Rockwell.
The project :
- Develop, test and validate software enhancements for CNC machine tools.
- Optimize software performance and stay at the cutting edge of technology.
- Collaborate with other engineers to integrate software solutions.
- Maintain existing software and provide technical support to users.
Project Manager - Equipment Design
We are looking for a proactive and detail-oriented Project Manager in Equipment Design to lead the development, design, and implementation of process equipment within a regulated environment. You will oversee technical design activities from concept to qualification, ensuring compliance with engineering standards, project timelines, and GMP requirements.
Your role:
- Lead equipment design projects from feasibility through to commissioning and qualification.
- Coordinate mechanical, automation, and process design activities with internal and external stakeholders.
- Develop and review technical specifications, design documentation, and FAT/SAT protocols.
- Manage supplier relationships, including technical alignment, design reviews, and project follow-up.
- Ensure budget and schedule control across all project phases.
- Oversee change management and risk assessment related to equipment design and modifications.
- Support CQV teams during qualification phases and participate in design improvement workshops.
- Guarantee compliance with GMP, safety, and quality standards for all equipment.
Quality System Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
- Ensure compliance with regulatory standards and internal policies for all validation processes
- Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
- Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
- Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
- Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
- Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
- Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
- Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
- Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's Degree in Biomedical Engineering, Biotechnology, Science or equivalent
- 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
- Experience with validation processes and quality oversight, including data integrity
- Strong understanding of cGMP regulations and validation principles
- Experience with risk assessment, gap analysis, and CAPA processes
- Problem-solving ability with a focus on proactive solutions and process improvement
- 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)
