Sr Auditor, QA

1 month ago

Montreal, Canada Syneos Health Full time
Description Senior Auditor, Computer Systems Quality Assurance Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong. Job responsibilities Syneos Health Audits • Plans and conducts assigned audits. • Performs For Cause audits • Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management. • Reviews responses to audit findings for appropriateness and completeness. • Closes assigned audits. Customer Audits/Inspections • Prepares for and hosts or supports customer audits. • Prepares for and hosts or supports Regulatory Authority Inspections. Other • Serves as Lead Auditor on team-based Syneos Health audits. • Serves as Assisting Auditor on team-based Syneos Health audits. • Serves as a trainer and mentor to less experienced QA auditors. Supervision • Requires minimal instructions on day-to-day work and new assignments. Other tasks • May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs). • Performs other work-related duties as assigned. • Moderate travel may be required (up to 50%). Qualifications What we’re looking for • Requires a Bachelor’s degree in the science/health care field or equivalent with 5 years experience in GxP quality assurance auditing in the Pharma or CRO sector. • Previous experience in the conduct of multiple audit types (e.g. vendors, process, computer system validation). • Previous experience in supporting customer audits or regulatory inspections in a plus. • Excellent Knowledge of GxP regulatory requirements with inn depth knowledge of Computer Systems Quality. • Knowledge of ISPE GGAMP5 concepts is preferred. • Knowledge of Medical and technical terminology related to the audit types to be conducted. • Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency). • Able to handle multiple tasks to meet timelines in dynamic environment. • Strong organizational, presentation and interpersonal skills. • Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds. • Ability to negotiate, problem solve and provide constructive feedback. • Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

  • Sr Auditor, QA

    1 month ago

    Montreal, Canada Syneos Health Full time

    Description Senior Auditor, Computer Systems Quality Assurance Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...

  • Sr Auditor, QA

    1 month ago

    Montreal, Canada Syneos Health Full time

    Description Senior Auditor, Computer Systems Quality Assurance Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...

  • Sr Auditor, QA

    1 month ago

    Montreal, Canada Syneos Health Full time

    DescriptionSenior Auditor, Computer Systems Quality AssuranceSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and...

  • Sr. Test Analysts with Automation experience, to test Websites on both desktop and mobile devices

    4 weeks ago

    Montreal, Canada S.i. Systems Full time

    Sr. Test Analysts with Automation experience, to test Websites on both desktop and mobile devices (iOS, Android and 10’ devices). Key Skills/Experience required. Front-End Expertise: You are proficient in front-end technologies such as React, Angular, or Vue.js. Back-End Proficiency: You have a strong foundation in back-end technologies, including...

  • Sr. Test Analysts with Automation experience, to test Websites on both desktop and mobile devices

    4 weeks ago

    Montreal, Canada S.i. Systems Full time

    Sr. Test Analysts with Automation experience, to test Websites on both desktop and mobile devices (iOS, Android and 10’ devices).Key Skills/Experience required. Front-End Expertise: You are proficient infront-end technologiessuch asReact, Angular, or Vue.js. Back-End Proficiency: You have a strong foundation inback-end technologies,including server-side...

  • Senior Software QA Engineer

    7 months ago

    Montreal, Canada TTC Full time

    About TTC The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost.  ...

  • Senior Software QA Engineer

    4 months ago

    Montreal, Canada Test Dev Tools Full time

    The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost.Perks of working for...

  • QA software engineer F/H

    4 months ago

    Montreal, Canada The Testing Consultancy Limited Full time

    p>The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost. Perks of working...

  • Bilingual Senior Software QA Engineer

    6 months ago

    Montreal, Canada TTC Full time

    About TTC The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost.  ...

  • Audit Senior

    1 month ago

    Montreal, Canada Innovaderm Research Full time

    Senior Auditor, Clinical Quality and ComplianceThe role of the Sr. Auditor, Clinical Quality and Compliance is to act as lead person in establishing audit plans, assessing/securing compliance in study conduct and to provide strong support to operations via GxP consultation.This role will be perfect for you if:You approach challenges with an understanding of...

  • Sr. Java Tech Lead

    7 months ago

    Montreal, Canada Prolifics Full time

    Overview Prolifics is seeking for a Sr. Java Developer to join our Digital Experience Practice Team. The successful candidate will be a highly motivated team player and will have significant experience in application development, a strong technical background and good communication skills. He/she will interact directly with the users and with other...

  • Tax Compliance Specialist

    4 weeks ago

    Montreal, Quebec, Canada dormakaba International Holding AG Full time

    Job DescriptionWe are seeking a highly skilled Tax Manager to join our team in Montreal, QC.About the RoleThis is a unique opportunity to work with a leading global provider of access solutions for schools, banks, airports, hospitals, and hotels. As a Tax Manager, you will be responsible for all tax compliance, reporting, and auditing requirements for two of...

  • Software Quality Assurance Lead

    3 weeks ago

    Montreal, Quebec, Canada Test Dev Tools Full time

    The Testing Consultancy (TTC) is a global specialist software testing company that assists organizations in transforming their software delivery processes. TTC offers broad capabilities across various testing areas, enabling clients to increase the speed and quality of software development while reducing risk and cost.Salary Estimate:$120,000 - $180,000 per...

  • Taxation and Compliance Specialist

    2 weeks ago

    Montreal, Quebec, Canada dormakaba International Holding AG Full time

    As a Tax Manager at dormakaba International Holding AG, you will play a crucial role in ensuring compliance with all tax-related regulations. This position is based in Montreal, QC, and involves overseeing tax compliance, reporting, and auditing requirements for two of our subsidiaries in Canada.The ideal candidate will have a strong background in accounting...

  • DevOps Engineer

    2 months ago

    Montreal, Canada S.i. Systems Full time

    Position: Sr. DevOps Engineer to provision cloud infrastructure on AWS, Snowflake, and Databricks resources for a major insurance client Duration: 6 months with possible extension Location: Hybrid (twice a week in Toronto or Montreal) Must haves: 5+ yrs exp as a DevOps Engineer within AWS cloud environment (S3, Lambda, IAM, CloudWatch, VPC, Data Backup, AWS...

  • Quality Assurance Software Engineer In Test H/F

    4 months ago

    Montreal, Canada Test Dev Tools Full time

    p>The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost.Perks of working...

  • Gestionnaire Fiscal

    3 months ago

    Montreal, Canada dormakaba International Holding AG Full time

    As a leading global provider in the access solutions market for schools, banks, airports, hospitals, hotels, and many more, we enable seamless movement within secure, safe, and sustainable places. With around 16,000 employees worldwide, EVERY team member contributes to our mission and can make a positive difference. p>CE QUE VOUS FEREZCE QUE NOUS...

  • Senior Software QA Engineer Montréal, Quebec, Canada

    4 months ago

    Montreal, Canada The Testing Consultancy Limited Full time

    The Testing Consultancy (TTC) is a global specialist software testing company with a focus on helping organizations transform the way they deliver quality software. We have broad capabilities across a wide range of testing areas that enable our clients to increase the speed and quality of software development while reducing risk and cost. Perks of working...

  • Financial Planning

    2 months ago

    Montreal, Canada Macdonald, Dettwiler And Associates Corporation Full time

    p>Job Category: Accounting & FinanceRequisition Number: ANALY007839Apply nowPosted: October 30, 2024Full-TimeLocationsShowing 1 locationBuilding the space between proven and possible, MDA Space (TSX:MDA) is a trusted mission partner to the global space industry. A robotics, satellite systems and geointelligence pioneer with a 55-year+ story of world firsts...

  • Sr Manager, Quality Assurance/Quality System-Gestionnaire principal, assurance qualité et conformité

    7 months ago

    Montreal, Canada Grifols Full time

    Vous souhaitez rejoindre une équipe internationale qui travaille à l'amélioration de l'avenir des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis sa fondation à Barcelone en 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le...