Documentation Manager – Vaccine

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    7 hours ago
  • Category:
    Health Care

Reference No. R2575778 Position Title: Documentation Manager – Vaccine Department: Process Engineering Type of Employment: Temporary – Full Time Location: Sanofi Pasteur Limited, Toronto, Ontario Sanofi Pasteur: The world’s leading vaccine company Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Summary of Purpose: This role involves providing documentation management support towards the engineering, commissioning and qualification, validation, handover of the new facility, including all of the new process control equipment and systems. The Document Controller for the project would be a member of the on-site Project Documentation Control Team, which is tasked with providing direct support to the C&Q Documentation Leadership, Engineering System Owners, and C&Q Methods Team. The document controller will be also expected to be the AutoCAD coordinator to be directly involved in the handover of drawings including minor updating and maintaining of drawings for the project. Key Accountabilities: Provide an organized classification and document naming structure used to effectively manage, locate and store documents produced by within the selected document repository environment. Ensure the security and integrity of documents stored within the project document repository environment. Manage the intake, filing, retention, and issuance of project-related documentation to support C&Q activities throughout all phases of the project. Support internal and external resources with managing red-lines of project lifecycle documentation and drawings. Maintain vendor, construction and engineering turnover documentation packages in electronic and physical document repository environments. Follow and enforce GDP requirements on all documentation submissions and revisions. Collaborate with the necessary departments to ensure that the document control practices used are in compliance with local site and global corporate policies and procedures. Manage the intake, filing, retention, and updating of drawings including AutoCAD files related to the B100 project. HSE Requirement and Statement: Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work. Participates in the investigation of incidents and work-related illnesses. Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner. Takes every reasonable precaution to ensure the health and safety of staff. Ensures that protective equipment and clothing required is used by staff. Cooperates and assists the Joint Health and Safety Committee in carrying out its functions. Advises staff of any potential or actual health and safety hazard of which they are aware. Context of the Job: Ability to work in a collaborative shared space (Obeya) in a large and complex project environment where quick critical thinking and decision making is required. Technical aptitude/understanding across a broad number of subjects including vaccine processes and equipment, HVAC systems, building and equipment maintenance. Ability to lead, engage and work with a spectrum of roles within the organization. This includes unionized trades, salaried managers, technical services support functions, quality, production and supporting functions. Dimensions and Scope: Financial dimensions : Potential impact on project budget Human Resources dimensions: NA Statistical dimensions: NA Health & Safety dimensions: NA   Education and Experience: College degree 5+ years of document control experience, preferably working within a bio/pharmaceutical manufacturing environment 5+ years providing document control support for large, multi-year CapEx projects within the Life Sciences industry Minimum Bachelor’s degree or certificate with relevant working experience Proficient with MS Office suite applications (e.g. MS Word, Excel, Power Point) and collaboration platforms such as Fieldwire, SharePoint, e-doc management systems Experience with AutoCAD file management and updating of AutoCAD files including maintaining/managing x-refs related to multi-discipline drawings Excellent coordination and organizational skills Excellent communication skills Excellent reading and writing skills in the English language Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Sanofi, Empowering Life #GD-SP   #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.