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    Job · 18857323

    BENGALURU · FULLTIME

    Manager CQA

    Althera Laboratories India logo

    Althera Laboratories India

    Bengaluru · onsite · Posted 29d ago

    Sourced fromNaukri
    Undisclosed13–18 yrsfulltimeBengaluru

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    Section · 01

    About this role

    Position Overview

    We are looking for an experienced and dynamic Manager / Senior Manager Corporate Quality Assurance to strengthen our Corporate QA function and support quality governance across manufacturing sites and external partners.


    The ideal candidate should have 13-18 years of experience in the pharmaceutical industry, with strong exposure to European regulatory requirements, EU GMP, regulatory inspections/audits, Quality Management Systems and people management. Experience in handling or supporting European customer/regulatory audits and working in a corporate/CQA environment will be preferred.


    Role & responsibilities

    • Lead Corporate QA activities and ensure effective implementation of GMP and Quality Management Systems across sites.
    • Manage European regulatory and EU GMP compliance requirements.
    • Lead/support European regulatory, customer and GMP audits, including audit preparation, responses and CAPA closure.
    • Drive QMS elements including Deviation, CAPA, Change Control, OOS/OOT, QRM, PQR/APQR and Supplier/CMO Quality Management.
    • Provide corporate QA oversight and support quality governance across manufacturing sites.
    • Lead, mentor and develop the QA team and effectively manage cross-functional stakeholders.

    Preferred candidate profile

    • 1318 years of pharmaceutical QA experience.
    • Currently at Manager/Senior Manager level with demonstrated people-management experience.
    • Strong European regulatory / EU GMP exposure.
    • Hands-on European audit-facing experience is essential/preferred.
    • Corporate QA (CQA) exposure preferred.
    • Excellent communication, leadership, analytical and stakeholder-management skills.

    Interested candidates may share their updated CV with relevant European audit and CQA experience.

    Sourced from naukri

    Section · 02

    Skills

    European AuditcqaEuropeanCorporate Quality AssuranceQuality AssurancecomplianceQuality Audit

    Section · Company

    About Althera Laboratories India

    Althera Laboratories India logo

    Althera Laboratories India

    Pharma

    Bangalore / Bengaluru, Karnataka

    India

    ₹9.8L PA avg

    Avg at Althera Laboratories India

    About

    About Company


    Althera is a Pharmaceutical company involved in Development and commercialization organization with operations in Europe and ROW market. The company headquartered is in Ireland.


    Our mission is to make significant positive impact on lives of patients by bringing to market innovative and complex products through our own development and in partnerships with other innovators.


    We believe our patient focused values are enduring and foundational to the long-term success of our company.

    Industries

    BiotechnologyHealth CareLife ScienceManufacturingMedicalPharmaceutical

    Employee ratings

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    3.6/ 5

    Culture

    2.6

    Career growth

    3.3

    Work-life

    3.2

    Employees rate it well for

    Job Security41Compensation & Benefits38

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