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    Quality Analyst Iii

    Teva Pharmaceuticals
    8+ years
    Not Disclosed
    Gajraula
    10 July 26, 2024
    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, 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

    Who We Are

    At Teva Pharmaceuticals, we are on a mission to make healthcare more affordable and accessible, improving the lives of millions globally. Our commitment unites our diverse team across nearly 60 countries, each bringing unique perspectives and backgrounds. We are the world’s leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization’s Essential Medicines List. Every day, at least 200 million people around the world take one of our medicines. We continuously strive to expand our impact and welcome new talent to help us in this endeavor.

    How You’ll Spend Your Day

    • Regulatory and Compliance Audits: Manage interactions with regulatory authorities and external compliance audits, including customer audits. This involves communicating, tracking, and resolving any observations.
    • Regulatory Compliance and CAPA Implementation: Assess the site’s regulatory compliance status, implement Corrective and Preventive Actions (CAPA) based on critical observations from other Teva sites, and ensure the site is inspection-ready at all times.
    • Internal Compliance Audits: Perform, report, and manage internal compliance audits, ensuring communication, tracking, and resolution of any findings.
    • Regulatory and Quality Compliance Review: Review regulatory and quality compliance requirements, inspect outcomes, and conduct gap assessments. Monitor corrective action plans as necessary.
    • Licensing and Quality Council Meetings: Maintain appropriate site licensing with regulatory bodies and execute site Quality Council meetings, including preparation, presentation, and tracking of actions.
    • Quality Technical Agreements (QTA): Establish and review QTAs with suppliers, subcontractors, service providers, and customers (including TAPI as a supplier).
    • Supplier and Material Oversight: Oversee and review suppliers and materials used in production and processes.
    • Site Master File Management: Draft, approve, and maintain the Site Master File (SMF).
    • Quality Interface and Documentation: Serve as the quality interface with internal and external customers for QTAs, supplier qualifications, issue resolution, product information, and movement of materials, products, or processes. Manage document processing, including SOPs, production records, test methods, protocols, reports, and labeling.
    • Additional Responsibilities: Take on additional tasks as assigned by the Manager – QA or Site Quality Head.

    Your Experience and Qualifications

    • Educational Background: MSc in Chemistry or M.Pharm.
    • Experience: 8+ years of experience in a related field.

    Reports To

    Senior Manager Quality Assurance

    Teva’s Equal Employment Opportunity Commitment

    Teva Pharmaceuticals is dedicated to providing equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status. We are committed to fostering a diverse and inclusive workplace. If contacted for a job opportunity, please inform us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information will be kept confidential and used solely for providing an accessible candidate experience.

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