Qualification & Validation Specialist, Report Issuance

Year    Hyderabad, Telangana, India

Job Description


Job Title: Qualification & Validation Specialist, Report IssuanceJob Location: Hyderabad, Telangana, IndiaJob Location Type: On-siteJob Contract Type: Full-timeJob Seniority Level: Entry levelAbout The JobOur Team:Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability interoperability and thus accelerate impact on global health.The Global MS Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global MS teams by acting as a crucial link between our RD and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.Main responsibilities:

  • Include references to relevant documents essential for the qualification process
  • Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements
  • Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and updates
  • Schedule formal consolidated review and approval meetings for qualification protocols
  • Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met
  • Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities
  • Ensure all documentation complies with overall documentation standards
  • Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes
About You
  • Experience: Professional experience in general documentation and project management
  • Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex dynamic environments
  • Technical skills: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point
  • Education: Bachelors degree in business administration, life sciences, or a related field
  • Languages: Excellent English communication and writing, French or other Languages in addition preferred
Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnt happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnt happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!xefxbbxbfLifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.xefxbbxbfxefxbbxbf xefxbbxbf

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Job Detail

  • Job Id
    JD3537944
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year