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    Risk And Compliance Specialist

    Accenture
    7-11 years
    Not Disclosed
    Bangalore
    10 May 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Risk and Compliance Specialist
    Skill Required: Risk & Compliance - Internal Audit Quality Assurance
    Designation: Risk and Compliance Specialist
    Qualifications: Bachelor of Pharmacy
    Years of Experience: 7 to 11 years
    Language - Ability: English - Expert

    About Accenture:
    Accenture is a global professional services company offering Strategy and Consulting, Technology and Operations services, and Accenture Song— powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. With 699,000 employees serving clients in over 120 countries, Accenture embraces change to create value and shared success.

    Roles and Responsibilities:

    • Analyze and solve moderately complex problems, potentially creating new solutions and adapting existing methods and procedures.
    • Understand the strategic direction set by senior management and align team goals accordingly.
    • Interact with peers, management levels, and clients, with guidance provided for determining methods and procedures on new assignments.
    • Decisions made in this role often impact the team and may involve managing small teams or work efforts at client sites or within Accenture.
    • Note: This role may require working in rotational shifts.

    Overall Purpose of the Job:
    To implement and comply with Quality Management System (QMS) and Audit & Inspection management processes across pharma projects. Responsibilities include performing compliance reviews, publishing reports with actions, providing closure guidance, designing and recommending effective controls to mitigate risks, and helping service delivery teams prepare for client/external audits.

    Key Responsibilities:

    • Develop the Audit Schedule for the Fiscal year and conduct audits as per schedule.
    • Monitor compliance to the audit schedule and provide support during client audit/regulatory inspections.
    • Implement/comply with QMS procedures and develop SOP/Guidance documents for QGO.
    • Provide training on GxP requirements and review/change requests, performing impact assessments and seeking approvals.
    • Collaborate with stakeholders, prioritize workload, and manage risks effectively.
    • Ensure timely closure of CAPAs for Inspections/client audits and maintain QA document repository.
     

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