QA Engineer - F/H/X

We are looking for a QA Engineer - F/H/X to join our team in Valais, Switzerland.

Your missions:

• Ensure compliance of manufacturing and QC activities with GMP, ICH and local/international regulatory requirements
• Review and approve batch records, SOPs, validation protocols and reports (process, cleaning, analytical methods, computerized systems)
• Manage quality events: deviations, OOS/OOT, complaints, change controls and associated CAPA
• Participate in the implementation, maintenance and continuous improvement of the Quality Management System (QMS)
• Prepare, support and follow up internal audits, customer audits and health authority inspections
• Monitor quality KPIs, perform trend analyses and propose improvement actions
• Contribute to product quality reviews and periodic reviews of the quality system
• Ensure data integrity and full traceability of operations and results (ALCOA+)

Your profile:

• You have at least 7 years of experience in Quality Assurance in GMP environment
• You have a strong knowledge of EU GMP, ICH guidelines and local health authority requirements (e.g. ANSM)
• You have proven experience in managing deviations, CAPA, change controls and OOS/OOT investigations
• You are used to deal with audits and inspections (internal, client, health authorities)
• You have a good understanding of Quality Management Systems (QMS) and continuous improvement methodologies
• You can review and approve GMP documentation (SOPs, batch records, protocols, reports) with high attention to detail
• French and English fluent.
• You demonstrate strong communication and interpersonal skills, with a pedagogical approach towards operational teams and an analytical mindset with problem-solving skills

What we offer:

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Amaris Consulting, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

Job description

We are looking for a QA Engineer - F/H/X to join our team in Valais, Switzerland.

Your missions:

• Ensure compliance of manufacturing and QC activities with GMP, ICH and local/international regulatory requirements
• Review and approve batch records, SOPs, validation protocols and reports (process, cleaning, analytical methods, computerized systems)
• Manage quality events: deviations, OOS/OOT, complaints, change controls and associated CAPA
• Participate in the implementation, maintenance and continuous improvement of the Quality Management System (QMS)
• Prepare, support and follow up internal audits, customer audits and health authority inspections
• Monitor quality KPIs, perform trend analyses and propose improvement actions
• Contribute to product quality reviews and periodic reviews of the quality system
• Ensure data integrity and full traceability of operations and results (ALCOA+)

Your profile:

• You have at least 7 years of experience in Quality Assurance in GMP environment
• You have a strong knowledge of EU GMP, ICH guidelines and local health authority requirements (e.g. ANSM)
• You have proven experience in managing deviations, CAPA, change controls and OOS/OOT investigations
• You are used to deal with audits and inspections (internal, client, health authorities)
• You have a good understanding of Quality Management Systems (QMS) and continuous improvement methodologies
• You can review and approve GMP documentation (SOPs, batch records, protocols, reports) with high attention to detail
• French and English fluent.
• You demonstrate strong communication and interpersonal skills, with a pedagogical approach towards operational teams and an analytical mindset with problem-solving skills

What we offer:

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Amaris Consulting, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

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