QA Engineer - F/H/X

ppWe are looking for a bQA Engineer - F/H/X /b to join our team in Valais, Switzerland. /p h3bYour missions: /b /h3 ul liEnsure compliance of manufacturing and QC activities with GMP, ICH and local/international regulatory requirements /li liReview and approve batch records, SOPs, validation protocols and reports (process, cleaning, analytical methods, computerized systems) /li liManage quality events: deviations, OOS/OOT, complaints, change controls and associated CAPA /li liParticipate in the implementation, maintenance and continuous improvement of the Quality Management System (QMS) /li liPrepare, support and follow up internal audits, customer audits and health authority inspections /li liMonitor quality KPIs, perform trend analyses and propose improvement actions /li liContribute to product quality reviews and periodic reviews of the quality system /li liEnsure data integrity and full traceability of operations and results (ALCOA+) /li /ul h3bYour profile: /b /h3 ul liYou have at least 7 years of experience in Quality Assurance in GMP environment /li liYou have a strong knowledge of EU GMP, ICH guidelines and local health authority requirements (e.g. ANSM) /li liYou have proven experience in managing deviations, CAPA, change controls and OOS/OOT investigations /li liYou are used to deal with audits and inspections (internal, client, health authorities) /li liYou have a good understanding of Quality Management Systems (QMS) and continuous improvement methodologies /li liYou can review and approve GMP documentation (SOPs, batch records, protocols, reports) with high attention to detail /li liFrench and English fluent. /li liYou demonstrate strong communication and interpersonal skills, with a pedagogical approach towards operational teams and an analytical mindset with problem-solving skills /li /ul h3bWhat we offer: /b /h3 ul liAn international community, bringing together 110+ different nationalities /li liAn environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities /li liA robust training system with our internal Academy and 250+ available modules /liliA vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.) /li liAt 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. /li /ul pAmaris 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. /p h3Who are we? /h3 pbAmaris Consulting /b 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. /p h3Job description /h3 pWe are looking for a bQA Engineer - F/H/X /b to join our team in Valais, Switzerland. /p h3bYour missions: /b /h3 ul liEnsure compliance of manufacturing and QC activities with GMP, ICH and local/international regulatory requirements /li liReview and approve batch records, SOPs, validation protocols and reports (process, cleaning, analytical methods, computerized systems) /li liManage quality events: deviations, OOS/OOT, complaints, change controls and associated CAPA /li liParticipate in the implementation, maintenance and continuous improvement of the Quality Management System (QMS) /li liPrepare, support and follow up internal audits, customer audits and health authority inspections /li liMonitor quality KPIs, perform trend analyses and propose improvement actions /li liContribute to product quality reviews and periodic reviews of the quality system /li liEnsure data integrity and full traceability of operations and results (ALCOA+) /li /ul h3bYour profile: /b /h3 ul liYou have at least 7 years of experience in Quality Assurance in GMP environment /li liYou have a strong knowledge of EU GMP, ICH guidelines and local health authority requirements (e.g. ANSM) /li liYou have proven experience in managing deviations, CAPA, change controls and OOS/OOT investigations /li liYou are used to deal with audits and inspections (internal, client, health authorities) /li liYou have a good understanding of Quality Management Systems (QMS) and continuous improvement methodologies /li liYou can review and approve GMP documentation (SOPs, batch records, protocols, reports) with high attention to detail /li liFrench and English fluent. /li liYou demonstrate strong communication and interpersonal skills, with a pedagogical approach towards operational teams and an analytical mindset with problem-solving skills /li /ul h3bWhat we offer: /b /h3 ul liAn international community, bringing together 110+ different nationalities /li liAn environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities /li liA robust training system with our internal Academy and 250+ available modules /li liA vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.) /li liAt 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. /li /ul pAmaris 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. /p h3Who are we? /h3 pbAmaris Consulting /b 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. /p /p #J-18808-Ljbffr