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BriefCase

Trainee / Quality Auditor Job in Vimta Labs Limited

Trainee / Quality Auditor

Vimta Labs Limited 4+ weeks ago
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Job Summary
    Primary Responsibilities:
  • Conduct study and process audits in Clinical Research division to verify the division s systems, process and out comes comply to Applicable guidelines and GXP s, Regulatory requirements,Sponsor Requirements.Review protocols, study documents and procedures for compliance.
  • Identify documents and report findings, including any deviations from SOPs, protocols and Non conforming works. Communicate the findings to the auditees, Head of the division and Quality Manager.
  • Aid in continuous improvement of management system. Assist Quality Manager in maintaining all QA correspondence.
  • Maintenance of SOPs of BA department and update Master list of SOPs.
  • Verify Method Validation protocols, Method Validation Reports (MVR, PMVR and SMVR) and Final STPs generated by BA department.
  • Verify individual subject concentrations for bioanalytical report preparation. and Bioanalytical Reports (BA Report, Repeat Analysis & ISR).
  • Verify Calibration data pertaining to the equipment and maintain a copy of updated list of the same.
  • Escalate to the management through through Quality Manager, where resolutions of audit findings are inadequate.
  • Review SOP s as necessary and distribute the same to the concerned departments.
  • Conduct Routine Process Audits
  • Represent QA at operational and cross functional meetings and provide training to technical staff on subjects related to Vimta s management system.
    • Secondary Responsibilities:
  • To perform QA activities in other departments on need basis and assist QA staff as and when required.
  • To give training forms and initiate training records.
  • To provide documents for self reading to new recruits.

Qualification :
M.Pharm./ B. Pharm.
Experience Required :

1 to 3 Year

Vacancy :

2 - 4 Hires

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