- 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)
Project Director - Major CAPEX (Aseptic Filling Line)
Location: Neuchâtel
Start date: Asap
Workload: 100%, on site
To join our Life Sciences team in Neuchâtel, we are looking for a Project Director - Major CAPEX (Aseptic Filling Line).
Lead and coordinate a large-scale capital investment project for a new aseptic filling line. Oversee planning, budget, and milestones, ensuring smooth transition from project phase to operations. Act as the project management expert guiding technical teams and senior leaders.
The project:
- Manage project completion, including Engineering Runs (ER) and Process & Performance Qualification (PPQ).
- Coordinate communication and reporting with site leadership, global teams, and external partners.
- Track and control project schedules, budgets, resources, and risks.
- Ensure compliance with policies and good project management practices.
- Facilitate meetings, support change management, and manage handover to operations.
- Develop contingency and risk mitigation plans.
Project Manager, Methods - Investment Maintenance
Location: Geneva, Switzerland
Start date: January 2026
Staffing: 100%, on site
As part of the development of our industrial activities, we are looking for a Methods Project Manager to support maintenance in the implementation of investment projects.
Your role will be to represent maintenance on projects, prepare for the integration of new equipment, and guarantee its maintainability throughout its life cycle.
Mission:
- Participate in equipment acquisition projects and monitor their progress.
- Managing feedback and gathering internal requirements.
- Coordinate the teams and partners involved.
- Ensure compliance with technical specifications and schedules.
- Develop and monitor project performance indicators.
- Prepare maintenance of new equipment (spare parts, documentation, maintenance plans, training).
- Carry out maintenance and logistics reviews during and at the end of the project.
Project Manager - Hospitals - part-time
Location: Geneva, Switzerland
Start date: November 2025
Job occupancy: 60% for 1 year
We are looking for a part-time Project Manager / PMO consultant to manage a project portfolio in a medical division of our hospital client .
Mission:
1. Management of the department's project portfolio
- Preparation and updating of monitoring and reporting dashboards.
- Examination of project announcements and preparation of the elements required for the departmental committee's decision.
- Use of One2Team PPM software for project tracking and coordination.
- Development of a departmental roadmap in line with the client's corporate strategy.
2. Project management
- Manage two projects, including planning, risk management, stakeholder coordination and documentation.
- Participation and reporting to steering committees.
- Projects concerned: building renovation and refurbishment.
3. Methodological support for departmental and service projects
- Provide methodological support for priority projects, including: system implementation, development of a new concept and relocation of a unit, extension and securing of a unit, renovation of several units.
Continuous Improvement Project Manager - Industrial F/H
We are recruiting a Continuous Improvement Project Manager - Industrial F/H 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 Continuous Improvement Project Manager - Industrial F/H, your missions will be :
- Deploy the continuous improvement process across all sectors and ensure overall coordination of the approach.
- Define the roles and responsibilities of those involved at each stage of the process.
- Design and run an effective session routine, in line with the objectives of the approach.
- Set up a coaching system to ensure that the process runs smoothly and is sustainable.
- Contribute to the implementation and evolution of audits, while defining relevant performance indicators.
- Structure and formalize the approach through regular reporting and presentations to management.
- Develop the skills of stakeholders (operations, industrialization, support functions) and support change management.
Watchmaking Product Industrialization Methods Engineer F/H
We are recruiting a Watchmaking Product Industrialization Methods Engineer F/H 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 Methods Engineer F/H, your responsibilities will include :
- Take charge of technical problems in several production sectors.
- Analyze and frame requests, assess their impact and coordinate the implementation of changes with business teams.
- Manage the deployment of changes in production, monitoring the schedule and associated deliverables.
- Design and deploy a centralized tracking dashboard for all requests.
- Organize regular reporting points with Production teams and the business lines concerned.
- Lead continuous improvement projects (CIP) upstream of the change flow.
- Monitor and control references to be launched in production whose industrial files are incomplete.
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)
