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Sun Pharma

Officer - QC

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  • Posted 5 hours ago
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Job Description

Experience: 3+ years

Qualification: MSc

  • Approval authority:
  • Extra page issuance form.
  • Batch internal release certificate and transfer note.
  • Breakdown memo perform impact analysis on product quality and sign for QA.
  • Tool set checking record.
  • Release of bulk product for further stage.
  • Key execution support for on-the-floor QA activities.
  • Witness key operation steps:
  • Area cleanliness and Cleaning Schedules.
  • Equipment cleanliness.
  • Start-up Activities.
  • Cleaning Documentation.
  • Verify key activities:
  • Monitor GMP and compliance activities:
  • Clean equipment.
  • Equipment cleaning and use logs.
  • Documentation practices.
  • Labelling practices throughout operations.
  • First coded approvals
  • Reporting of Internal quality observations.
  • Reporting of incidents.
  • Bulk batch approval to proceed.
  • Follow-up on open investigations, CAPA and audit observations.

TASKS

  • Follow procedures for area QA oversight.
  • Collection and transfer of samples (completion of test request) as per approved batch record or protocol.
  • Verification of the sampling instrument cleanliness.
  • Perform in-process checks or verifications as required in QA approved batch records or protocols.
  • Reviewing of the batch manufacturing record for its completeness and reporting of the BMR observation.
  • Direct support during key production activities:
  • Process validation execution, including raw data checks and report preparation.
  • Characterization batches.
  • Various other approved protocols.
  • Preparation and trending of key process information and/or reports in support of protocols, CPV, incidents or CAPA follow-up.
  • Supporting operations in assisting or providing and documenting training when Required.
  • Suggest improvements to reduce chance for errors.

More Info

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About Company

Job ID: 147481421