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    Supplier Quality Auditor

    Gsk Plc
    3+ years
    Not Disclosed
    India Mumbai
    10 Feb. 13, 2025
    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 Role: Supplier Quality Assurance (SQ A&C) - GSK

    Location: India - Maharashtra - Worli Mumbai
    Posted Date: Jan 27, 2025

    Job Purpose:

    The purpose of this role is to ensure that material and service suppliers within the scope of SQ A&C meet applicable GSK and regulatory requirements. This includes the execution of assessments, management of supplier CAPA plans, and effective interfacing with the supply base to manage supplier issues.

    Key Responsibilities:

    Supplier Assessment, Approval & Compliance:

    • Perform Quality System assessments/audits of assigned suppliers to determine GMP approval status and document the findings in relevant systems within targeted timelines.
    • Agree on appropriate corrective and preventive action (CAPA) plans with suppliers and follow up to ensure completion within the agreed timelines.
    • Ensure that all audit-related documentation is communicated within targeted timelines, and CAPA documents are reviewed and responded to promptly.
    • Conduct For Cause/Target audits to support supplier complaints and changes due to significant quality incidents.
    • Maintain auditee profiles (supplier data) and keep records up to date with relevant information.
    • Support actions associated with supplier change controls/change notifications and ensure the completion of Quality Assurance Agreements (QAAs).
    • Lead/support third-party audits conducted by auditing firms or contract auditors to ensure compliance with GSK processes.

    Risk Management:

    • Identify and escalate high-risk issues to ensure stakeholders understand technical, regulatory, and quality risks and identify mitigating actions.

    Regulatory / Customer Inspection Support:

    • Provide relevant support to GSK sites during regulatory/customer inspections as assigned.

    Internal Supplier Quality Processes:

    • Participate in the development and implementation of internal Supplier Quality processes to ensure compliance with the GSK Quality Management System (QMS).
    • Complete all relevant training curriculums in a timely manner and remain updated with technical processes and industry trends.

    Interfaces:

    • Regularly interface with site Quality/Procurement, Procurement Commodity teams, SQ Ops/QSIM, and GSK suppliers to communicate audit results, CAPA plans, and any issues impacting materials, components, and services delivered to GSK sites.

     

    Educational Background:

    • Minimum Level of Education:
      • A Science degree and at least 3 years of relevant experience in Pharmaceutical/BioPharma/Vaccines manufacturing, quality operations, and/or supplier quality management.
    • Preferred Level of Education:
      • A Graduate degree in Biology, Chemistry, Pharmacy, Food/Chemical/Biotechnology, or an equivalent Engineering discipline.

    Why This Education is Required:

    To understand regulations, standards, and production processes of materials sourced by GSK and make risk-based decisions regarding supplier approval.

    Experience Requirements:

    • Proficiency in planning and executing audits to identify and reduce significant risks/non-compliance.
    • Knowledge of GMP and GSK quality requirements and ability to apply these to both GSK and supplier operations.
    • Ability to influence and negotiate with suppliers and internal stakeholders.
    • Good verbal and written communication skills to ensure clarity in the relay of issues, risks, and action plans.
    • Experience with Microsoft Office and the ability to learn and apply new software tools (e.g., audit management software, virtual meeting tools).

    Other Skills and Background:

    • Travel Requirements: Ability and availability to travel (locally, domestically, and internationally) to suppliers as needed for assessments.
    • Time Management: Strong ability to meet deadlines and complete tasks within required timelines.
    • Matrix Organization Skills: Ability to work effectively across multiple cultural and geographical boundaries.
    • Certification: Nationally recognized auditor certification or GSK Certified Auditor status preferred.

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