Associate

Malaysia, Malaysia

Job Description


Department DetailsRole Summary

  • Get trained on the assigned SOP\'s & ensure the training completed on-time for self as per the curriculum.
  • Performing In-process QA activities primarily routine in-process checks, line clearance as per SOP.
  • Online reviewing of batch records, logbook and monitoring of manufacturing and packing activities.
  • Initiation of Change Control, Deviations, and CAPA pertaining to Quality Assurance.
  • Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
  • Performing cGMP self-inspections including preparation of reports and follow-up CAPA.
  • Working and supporting the team for internal and external audits (regulators/customers/partners).
  • Ensure the Compliance to procedures in the Shop Floor
  • Involve in Sampling activities and AQL checks for visual inspection activities. 13.Ensure online documentation in the Shop floor.
  • Handling of issuance and control of master documents and archiving of documents.
  • Familiarisation of function and activities for Quality Control, Warehouse, Engineering & Maintenance, Instrumentation & Automation and Environmental, Health & Safety.
  • Review of batch records for Drug product manufacturing and packing, focusing on identification of any discrepancies in the batch processing.
  • Identify any Transcriptional errors, accuracy & missing attribute in executed documents during review.
  • Any other assignment given by Reporting Manager
Key Responsibilities
  • Get trained on the assigned SOP\'s & ensure the training completed on-time for self as per the curriculum.
  • Performing In-process QA activities primarily routine in-process checks, line clearance as per SOP.
  • Online reviewing of batch records, logbook and monitoring of manufacturing and packing activities.
  • Initiation of Change Control, Deviations, and CAPA pertaining to Quality Assurance.
  • Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
  • Performing cGMP self-inspections including preparation of reports and follow-up CAPA.
  • Working and supporting the team for internal and external audits (regulators/customers/partners).
  • Ensure the Compliance to procedures in the Shop Floor
  • Involve in Sampling activities and AQL checks for visual inspection activities. 13.Ensure online documentation in the Shop floor.
  • Handling of issuance and control of master documents and archiving of documents.
  • Familiarisation of function and activities for Quality Control, Warehouse, Engineering & Maintenance, Instrumentation & Automation and Environmental, Health & Safety.
  • Review of batch records for Drug product manufacturing and packing, focusing on identification of any discrepancies in the batch processing.
  • Identify any Transcriptional errors, accuracy & missing attribute in executed documents during review.
  • Any other assignment given by Reporting Manager
Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 4 - 7 years

Biocon

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Job Detail

  • Job Id
    JD1052068
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Malaysia, Malaysia
  • Education
    Not mentioned