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2 jobs found in Vaud

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    • lausanne, vaud
    • permanent
    Our client, an innovative company within medical devices industry in Lausanne is looking for a  Quality Assurance Engineer Start: AsapPermanent employment Your mission: • Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance• Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries• Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations• Interface directly with IT, Engineering and Vendors to develop CSV strategy • Provide support for quality system processes and best practices• Provide Quality compliance expertise and support as required by the organization • Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls) • Assist in resolution of deviations/ exceptions during qualification activities• Oversee and administer document lifecycle management as well as the Document Change Request process• Perform final approval of documents submitted through the change control process for format, completeness and review• Handle company Quality Audit process• Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards • Conduct training on quality assurance concepts and tools to the organization • Managing the site calibration program, the coordination of calibration activities and associated documentation. Education & Skills:• Bachelor of Science in an engineering or applied science discipline• 2-5 years' experience in the healthcare industry• Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards• Experience with statistical analysis concepts and techniques• Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly Language skills:• Fluent in English (level C1) with minimum B2 level in French 
    Our client, an innovative company within medical devices industry in Lausanne is looking for a  Quality Assurance Engineer Start: AsapPermanent employment Your mission: • Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance• Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries• Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations• Interface directly with IT, Engineering and Vendors to develop CSV strategy • Provide support for quality system processes and best practices• Provide Quality compliance expertise and support as required by the organization • Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls) • Assist in resolution of deviations/ exceptions during qualification activities• Oversee and administer document lifecycle management as well as the Document Change Request process• Perform final approval of documents submitted through the change control process for format, completeness and review• Handle company Quality Audit process• Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards • Conduct training on quality assurance concepts and tools to the organization • Managing the site calibration program, the coordination of calibration activities and associated documentation. Education & Skills:• Bachelor of Science in an engineering or applied science discipline• 2-5 years' experience in the healthcare industry• Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards• Experience with statistical analysis concepts and techniques• Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly Language skills:• Fluent in English (level C1) with minimum B2 level in French 
    • monthey, vaud
    • permanent
    Are you looking for your next role within Regulatory Affairs? Do you have experience in chemical drugs?In this case you should have a look at this opportunity!Our client, a private, Swiss-based biopharmaceutical company, mainly focused in oncology and bacterial infections, is looking for their next: REGULATORY AFFAIRS MANAGER, 100% - permanent role(Valais canton - Monthey area)Mission :Manage post marketing regulatory activities of drug products as well as regulatory activities of chemical pharmaceutical drug products under development. Key Responsibilities :- Maintenance of registration files - Coordinate with partners’ regional regulatory teams for global strategy - Define, develop and lead regulatory strategies for post-marketing and clinical development activities - Maintenance and update of the Product Information - Prepare and review regulatory submissions - Manage CMC activities for products under development - Internal Regulatory contact for Pharmacovigilance and Marketing and Business - Maintain policy & regulatory intelligence - Provide regulatory strategies for projects as RA representative in cross-functional teams Your profile :- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent - 5 years’ experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation - Experience in regulatory activities for Chemical Pharmaceutical Drug Products under development (phase 1 to phase 3) - Maintenance, Renewal, Extension of indications, - Previous experience in meeting with Health agencies,- Fluent in French and English - Strong attention to details and organizational skills required - Good written and oral communication, technical writing and editing skills  If you recognise yourself in this job description, do not wait any longer and apply directly! 
    Are you looking for your next role within Regulatory Affairs? Do you have experience in chemical drugs?In this case you should have a look at this opportunity!Our client, a private, Swiss-based biopharmaceutical company, mainly focused in oncology and bacterial infections, is looking for their next: REGULATORY AFFAIRS MANAGER, 100% - permanent role(Valais canton - Monthey area)Mission :Manage post marketing regulatory activities of drug products as well as regulatory activities of chemical pharmaceutical drug products under development. Key Responsibilities :- Maintenance of registration files - Coordinate with partners’ regional regulatory teams for global strategy - Define, develop and lead regulatory strategies for post-marketing and clinical development activities - Maintenance and update of the Product Information - Prepare and review regulatory submissions - Manage CMC activities for products under development - Internal Regulatory contact for Pharmacovigilance and Marketing and Business - Maintain policy & regulatory intelligence - Provide regulatory strategies for projects as RA representative in cross-functional teams Your profile :- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent - 5 years’ experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation - Experience in regulatory activities for Chemical Pharmaceutical Drug Products under development (phase 1 to phase 3) - Maintenance, Renewal, Extension of indications, - Previous experience in meeting with Health agencies,- Fluent in French and English - Strong attention to details and organizational skills required - Good written and oral communication, technical writing and editing skills  If you recognise yourself in this job description, do not wait any longer and apply directly! 

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