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    Qa Compliance Lead Auditor (Pv Quality Compliance)

    Fortrea
    2+ years
    Not Disclosed
    Bangalore Mumbai Pune
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time Remote 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 Description: Regulatory and Quality Assurance (QA) Lead Auditor at Fortrea

    Fortrea, a leading global contract research organization (CRO), is transforming drug and device development across the globe by providing innovative clinical development, patient access, and technology solutions. With operations in over 90 countries and a commitment to scientific rigor, Fortrea supports pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas.

    We are seeking a Regulatory and Quality Assurance (QA) Lead Auditor to join our team. In this role, you will lead regulatory compliance efforts and quality assurance processes, influencing key strategies and providing expertise on niche regulatory topics. This position is crucial to ensuring Fortrea’s commitment to regulatory excellence and process improvement across global operations.

    Essential Job Duties:

    • Conduct audit activities as outlined in the audit activity table, addressing both routine and complex audit requirements.
    • Lead the creation and implementation of global QA policies regarding the interpretation and application of regulations.
    • Serve as the subject matter expert, guiding internal teams and clients on specific regulatory matters.
    • Lead and host external audits/inspections (e.g., regulatory inspections, client audits) and ensure audit responses are managed and reviewed.
    • Report on quality metrics and implement corrective actions or process improvements via various forums such as Monthly Reports and Site Quality Reviews.
    • Manage or participate in global quality initiatives aimed at improving compliance and operational efficiency.
    • Act as a backup for the QA Manager, providing monthly activity reports and taking on related duties as assigned.
    • Ensure adherence to Regulatory Compliance and Quality Assurance responsibilities as per applicable controlled documents.
    • Support management in other duties as needed.

    Experience:

    • 8+ years of experience in the regulatory environment, particularly in GXP roles.
    • Expertise in specific regulations and multiple regulatory frameworks.
    • Experience as a lead auditor in regulatory settings.
    • Strong strategic communication skills, especially with clients.
    • Proven experience in leading process improvement initiatives.

    Qualifications:

    • Minimum of a Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related discipline.
    • A postgraduate degree (MSC or equivalent) in science or management-related field is preferred.
    • Relevant experience may be considered in lieu of formal education.

    About Fortrea: Fortrea is actively seeking innovative problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. Join us in revolutionizing the development process and delivering life-changing therapies to patients. In our collaborative work environment, your personal and professional growth will be supported, enabling you to make a meaningful impact.

    For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer: Fortrea is an Equal Opportunity Employer, fostering diversity and inclusion in the workforce and prohibiting discrimination or harassment of any kind. Employment decisions are based on business needs and the qualifications of individuals, without regard to race, religion, gender, disability, or other legally protected characteristics.

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