Senior Executive - MDM

4 - 7 years

5 - 8 Lacs

Posted:6 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Creation and Review of Master documents: Specification, standard testing procedure,
  • analysis and general procedure, raw materials and finished products in LIMS.
  • Initiation and tracking of QMS events and evaluation of impact on Master documents
  • Revision of Master documents: SPEC, STPs and general procedure based on the approved change control.
  • Ensuring RFT in documents by creating error free documents.
  • Implementation of Pharmacopeial changes and source change document.
  • Review and tracking of DMF in PLM and preparation of Master documents based on AMV/AMT/Evaluation report.
  • Handling of LIMS master data activities and resolving of SAP/LIMS related queries.
  • Creation and revision of Raw Data Sheet.
  • Preparation of Residual solvents justification reports.
  • Harmonization of SPEC/STP/RDS for API and Excipients.
  • Maintaining track wise discipline by tracking pending tasks, closure of quality events.
  • Ensuring compliance / completeness for applicable Logbook/Register.
  • Creation of harmonized templates for Spec/STP/RDS.
  • Tracking of CAPA assigned and checking on the task applicability to Master data team based on RCI.
  • Implementation of previous learning / improvement points to the upcoming projects /during subsequent revision of Spec/STP/RDS.
  • Co-ordination and conducting internal trainings and learning sessions for entire Master Data Team.

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Strides Pharma Science logo
Strides Pharma Science

Pharmaceuticals

Bangalore

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