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    Manufacturing Process Engineer - Hyderabad, India - Hetero

    Hetero
    Hetero Hyderabad, India

    3 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Responsible for Co-coordinating with the department head for availability of machines for Maintenance.

    Responsible to co-ordinate with contractors and sub-contractors for scheduling of work.

    Responsible for validation activities and Process, Utilities equipment Qualifications.

    Responsible to ensure that the appropriate equipment's validations are performed, recorded and reports are made available.

    Responsible for Change controls, Incidents / Deviations, CAPA activities.

    Responsible for Executing & coordinating for equipment qualifications for URS/DQ/IQ/OQ/PQ.

    Responsible for energy saving activities.

    Responsible for maintaining Quality Policy.

    Responsible for compliance to GMP and Safety Policy.

    Responsible for Data Integrity related Compliance.

    Major equipment experience required: Rapid Mixer Granulators, Fluid Bed Dryers / Processors, Blenders, Compression machines (Korsch, Killian, Sejong, Cadmach), Coating machines (Gansons, Solace), Capsule filling machines (AF90T, ZRO), Packing line equipments like CVC, BQS etc

    Spares management of Process equipment listed above

    Preventive maintenance through SAP, SAP knowledge to handle the engineering spares and services etc

    Handling of 21 CFR compliance requirements in process equipment listed above,

    Ensuring the work place safety, equipment level safety requirements assessment and implementation

    Building maintenance of clean rooms, maintaining audit readiness in the processing areas

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