Position: Other

Job type: Full Time, Permanent

Experience: 2 - 7 years

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Job content

Roles and Responsibilities

  • To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation
  • To review and approve analytical method validation protocols, Report, analytical method development report for routine analysis against the actual raw data, transfer, and stability protocol & summary report.
  • To review analytical related activity in change control, deviation, Incident, Out of specifications, CAPA, etc. as and when required.
  • To support in investigation of Incident, OOS and OOT to identify the root cause.
  • To ensure the analytical raw data, Audit trail of QC instruments and ensuring its adequacy, accuracy on periodic basis.
  • Review the raw material and packing material results.
  • Review the Bulk (in process) and Finished product results before batch release for GLP compliance.
  • Review of all QC related data to ensure the GLP compliance
  • To be a part of internal audit team (Self inspection).
  • To ensure the completeness of batch manufacturing records / online documentation of logbooks.
  • To ensure compliance for document issuance, distribution, retrieval and archival as per the procedure.
  • To review and ensure the compliance of retention sample and stability reports as per the procedure.
  • Review of risk assessment performed at site.

Thanks & Regards,

Neha Sharma

Asst. Manager - HR

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