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    Job · 12260387

    Crius Life Sciences logo

    Assistant Manager - Compliance Management

    Crius Life Sciences · Mumbai · onsite · Posted 65d ago

    Undisclosed7–10 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Role Overview -

    Accountable for the quality management system, compliance, and inspection readiness of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Report to the Director Safety and operate independently of the delivery line to provide objective quality oversight across all functions.

    Key Responsibilities -
    • Own and maintain the quality management system across the entire PV operation.
    • Lead deviation and CAPA management, including root cause analysis and effectiveness checks.
    • Drive ongoing audit and inspection readiness and lead the quality response during regulatory inspections and client audits.
    • Perform compliance monitoring against regulatory timelines and internal SLAs, identifying and escalating risks.
    • Own SOP and controlled document management, including periodic review and version control.
    • Conduct quality trend analysis across case processing, aggregate reports, literature, and affiliate functions, and drive corrective action.
    • Maintain a dotted-line relationship with the client quality contact and support client quality governance.
    • Deliver quality metrics and KPI/SLA compliance reporting to the Director Safety and client.

    Qualification - Degree in Pharmacy, Medicine, Pharm D, BHMS, BDS or equivalent

    Key Skills - PV administration and coordination | KPI, SLA and metrics reporting | MIS reporting | compliance trackers | Document management | Scheduling and meeting coordination | Client and internal team coordination | Safety database operational support

    We are an equal opportunity employer committed to fostering a diverse, inclusive, and respectful workplace. We welcome applications from all qualified candidates and do not discriminate on the basis of race, colour, religion, gender, gender identity or expression, sexual orientation, age, disability, marital status, or any other characteristic protected by applicable law. Employment decisions are based on qualifications, skills, experience, and business needs.





    Required Skills

    Quality management KPI/SLA Compliance Quality Trend Analysis Client Quality Governance Audit and inspection readiness Root Cause Analysis Deviation and CAPA Compliance Monitoring


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    Trend AnalysisDocument ManagementpharmacovigilanceOTCoperational supportRoot Cause AnalysisPharmacyHealthcareSchedulingGIT

    About Crius Life Sciences

    Crius Life Sciences logo

    Crius Life Sciences

    201

    employees

    ₹4.1L PA avg

    Avg at Crius Life Sciences

    About

    Soterius is a healthcare and life sciences services company specializing in pharmacovigilance, regulatory affairs, and clinical research support. It partners with pharmaceutical and biotech firms to ensure drug safety, compliance, and efficient development processes. By combining scientific expertise with technology-driven solutions, Soterius helps organizations meet global regulatory standards and deliver safe, effective therapies to patients.

    Industries

    Manufacturing

    Employee ratings

    10 reviews

    4.3/ 5

    Culture

    3.5

    Career growth

    3.0

    Work-life

    3.9

    Employees rate it well for

    Overall Company43Work-Life Balance42

    Find them on

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    Assistant Manager - Compliance Management · waiting for your command