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    Quality Assurance

    Sanofi
    2-5 years
    Not Disclosed
    Mumbai
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Quality Assurance

    Location: Mumbai

    Job Type: Permanent

    About Sanofi Consumer Healthcare:

    At Sanofi Consumer Healthcare, our mission is to build a healthier future by empowering people to take control of their health, encapsulated in our vision of “Health in Your Hands.” We are committed to developing trusted and beloved brands that enhance self-care for individuals and communities while supporting a healthier planet.

    We strive to integrate sustainability into our business practices and to operate responsibly, socially, and environmentally. Our goal is to create a work environment where our team can thrive, grow, and excel every day. We are looking for exceptional talent to help us shape the future of our Consumer Healthcare business and challenge industry standards.

    Job Description:

    As a Quality Assurance professional at Sanofi Consumer Healthcare, you will be integral to ensuring the highest quality standards in our products. Your role encompasses overseeing compliance with cGMP guidelines, managing quality agreements, conducting audits, and addressing technical complaints, among other responsibilities. You will be a key player in maintaining product quality and compliance across our operations.

    Key Responsibilities:

    1. CGMP Compliance and Product Release:

      • Ensure all aspects of pharmaceutical product manufacturing at CMOs comply with Sanofi Quality directives and relevant cGMP and regulatory requirements.
      • Oversee timely product releases according to registered specifications and local regulations.
      • Maintain coordination with various Sanofi functions such as Purchasing, Legal, Supply Chain, Drug Regulatory Affairs, and Marketing for operational compliance.

    2. Quality Agreements:

      • Maintain and review QA agreements with CMOs to ensure alignment with global templates and cGMP roles and responsibilities.
      • Perform periodic reviews and negotiate amendments to agreements based on identified needs and issues.

    3. Audit Management:

      • Conduct quality audits of CMOs and suppliers, ensuring audits are performed as scheduled.
      • Address critical and major findings with the Quality Head and Head QA, prepare audit reports, and ensure timely corrective and preventive actions.

    4. Product Technical Complaints:

      • Coordinate and communicate product technical complaints to CMOs for investigation.
      • Participate in the investigation and resolution of complaints, ensuring timely implementation of CAPAs.

    5. Quality Management System Compliance:

      • Manage quality issues including deviations, complaints, OOS, recalls, and stability failures in accordance with the Quality Management System.
      • Collaborate with the Central Cell QMS to register and address quality events and ensure effective execution of CAPAs.

    6. CMO Quality Reviews:

      • Conduct quality reviews for CMOs as per the SQR calendar and prepare detailed reports.
      • Ensure compliance with product dossiers and Pharmacopeia requirements and develop action plans for identified gaps.

    7. Regulatory Authorities Inspection:

      • Maintain quality and regulatory compliance at CMOs and ensure audit readiness for regulatory inspections.
      • Oversee compliance with local and export regulatory audits of contract manufacturing sites.

    8. New Drug Product Quality Evaluation:

      • Evaluate new drug product sites for compliance and review product-quality dossiers.
      • Identify gaps, develop action plans, and ensure timely implementation for new product evaluations.

    9. Project Management:

      • Lead and support technology transfer and continuous improvement projects.
      • Ensure compliance with Sanofi Technology Transfer standards and regulatory requirements, and facilitate smooth project execution.

    10. Quality Risk Assessment:

      • Continuously evaluate quality risks and escalate potential issues.
      • Work with the Central QMS Cell to perform risk assessments and manage critical quality issues.

    11. Other Responsibilities:

      • Ensure complete documentation of product-related records in Sanofi’s database.
      • Report KPIs and submit monthly reports timely.
      • Act as Deputy to the Peer Quality Manager when assigned or in their absence.

    Qualifications:

    • Experience:

      • Proven experience in quality assurance within the pharmaceutical or consumer healthcare industry.
      • Familiarity with cGMP guidelines, audit management, and quality management systems.

    • Skills:

      • Strong analytical, problem-solving, and project management skills.
      • Excellent communication skills and ability to collaborate effectively across teams.
      • Capability to manage multiple priorities and meet deadlines in a dynamic environment.

    • Education:

      • Bachelor’s degree in a relevant field such as Pharmacy, Life Sciences, or Quality Assurance.

    • Languages:

      • Fluent in English (spoken and written).

    Why Join Us?

    At Sanofi Consumer Healthcare, you will be part of a dynamic team committed to making a meaningful impact on global health. We offer opportunities for professional growth, a supportive work environment, and the chance to contribute to our mission of improving self-care and overall well-being.

    If you are passionate about quality and looking to make a difference, apply now to join our team!

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