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Educational Qualification: BTech/MSc/MTech
Experience: 2 -3 years
No of position: 01
Job Location : Bengaluru, India

Job Description:

  1. Shop floor Monitoring and execution of day to day activities of Manufacturing of drug substance.
  2. Handling of line clearance and dispensing activities (Drug Substances)
  3. Preparation, Review of Batch production records, Log registers and raw data sheets.
  4. Preparation and review of SOPS.
  5. Preparation and review of study protocols.
  6. Handling of deviations and its investigation and root cause analysis.
  7. Handling of CAPA and verification of CAPA effectiveness.
  8. Handling of change control assessments and verification of implementation status.
  9. Handling of self-inspections and its follow up.
  10. Review and online verification of the executed batch records.
  11. Knowledge on compliant investigation procedure.
  12. Knowledge on batch release procedures.
  13. Knowledge on cleaning validation and process validations.
  14. Knowledge on regulatory guidelines (WHO, FDA, and ICH etc.)
  15. Experience in handling of regulatory audits and customer audits (WHO/FDA)
  16. Knowledge on data integrity procedures/management.

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Please share the resumes on or before 21/01/2019

Bengaluru, India


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