Asst Manager - QA Investigation

Konnect HR
  • Mumbai
  • Confidential
  • 6-9 years
  • Views
  • 17 Dec 2018

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Ensure proper investigation tools have been used to identify the root cause/probable causes.
- Ensure correct CAPA is provided by the CMO as per the root cause that was arrived from the investigation.
- Investigator in Trackwise system & route it to the QA 

Desired Candidate Profile : Keyskills :qa root cause investigation sterile injectable CAPA Trackwise system USFDA EU Batch Release Operation Quality Lead KPI Metrics Change Control LIRs Deviation Quality Assurance

Desired Candidate Profile : Experience in USFDA & MHRA Audit.Exp in Sterile & Injectable Product.

Ensure that there are no overdue investigations in TrackWise.

Act as investigator in Trackwise system & route it to the Operational Quality Lead/respective QRM's for approval & disposition.

Competencies/Skill sets for this job

QA QA Investigation CAPA Quality Assurance Quality Control Operations

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About Organisation

Konnect HR