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    Country Quality Specialist

    Novartis
    2-3 years in QA/QC years
    Preffered by Company
    Hyderabad
    10 July 9, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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

    Country Quality Specialist

    Job ID: REQ-10014447
    Posted On: July 5, 2024
    Location: Hyderabad, India
    Division: Operations
    Business Unit: Innovative Medicines
    Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Functional Area: Quality
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Summary

    The Country Quality Specialist monitors quality governance and compliance within the country organization in all GxP-related areas (e.g., Supply Chain, C&F Warehouse, Market Complaints) to ensure that all operational business aspects comply with cGxP, legal and regulatory requirements, and the Novartis Pharma Corporate Quality Manual and Policies. The role aims to prevent significant quality issues or regulatory non-compliance that could lead to product stock-outs, withdrawals, approval delays, or negatively impact the company's financial performance and reputation.

    Key Responsibilities

    • Quality System Implementation: Ensure implementation, maintenance, and upgrading of the local Quality System and Standard Operating Procedures to drive compliance with all cGxP and Pharmacovigilance-related processes.
    • Quality Governance: Actively involve in quality governance and planning through the establishment and implementation of the annual Quality Plan, appropriate Key Quality Indicators, and Quality Risk Assessments.
    • Compliance Assurance: Ensure that a local Quality System and SOPs are in place for all GxP-related activities, maintaining cGMP compliance through training and internal audits.
    • Product Release: Ensure that all drug products are released according to registered specifications and local regulations, with a respective Change Control procedure in place.
    • Handling and Distribution: Ensure all aspects of handling and distribution of pharmaceutical products comply with Novartis Pharma Quality Manual, Policies, and relevant cGMP, regulatory, and legislative requirements.
    • Vendor Supervision: Visit, supervise, and coordinate CPO Vendor activities to ensure compliance with Novartis Standards.
    • Issue Resolution: Participate in resolving Critical Quality Issues (e.g., deviations, complaints, recalls) according to the Quality Assurance Agreement and Novartis Pharma Quality Manual, ensuring proper execution and documentation.
    • Change Management: Manage Change Requests from External Suppliers/Vendors or Novartis CPO according to Quality Assurance Agreement and Novartis SOPs.
    • Continuous Improvement: Prepare Quality trends and drive continuous improvement for process and product quality performance.
    • Communication: Provide quality presence and input to Compliance/Technical meetings with CPO Vendors, supporting internal functions (BD&L, CRO) by evaluating and deciding on new products as per Novartis Pharma Quality Manual and standards.
    • Documentation: Ensure proper filing of study documents in central files or hub locations.
    • Inspection Readiness: Take responsibility for inspection readiness for medical assessment activities and support regulatory authority inspections when needed.

    Essential Requirements

    • Experience: 2-3 years in QA/QC.
    • Knowledge: Understanding of cGMP and regulatory compliance for relevant operations like C&F cold chain.
    • Skills: Proficiency in communicating with vendors and internal customers, good presentation skills, and support for resolving GMP and GxP-related issues.

    Desirable Requirements

    • Education: B.Sc., B.Pharm with a Postgraduate Diploma is an added advantage.
    • Languages: Fluent in English and proficient in the local language.

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