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Trainee / Quality Auditor

1.00 to 6.00 Years   Hyderabad   22 Mar, 2022
Vimta Labs Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

      Secondary Responsibilities:
    • 1. 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.
    • 2. Identify documents and report findings, including any deviations from SOPs, protocolsand Non conforming works. Communicate the findings to the auditees, Head of the division and Quality Manager.
    • 3. Aid in continuous improvement of management system. Assist Quality Manager in maintaining all QA correspondence.
    • 4. Maintenance of SOPs of BA department and update Master list of SOPs.
    • 5. Verify Method Validation protocols, Method Validation Reports (MVR, PMVR and SMVR) and Final STPs generated by BA department.
    • 6. Verify individual subject concentrations for bioanalytical report preparation. and Bioanalytical Reports (BA Report, Repeat Analysis & ISR).
    • 7. Verify Calibration data pertaining to the equipment and maintain a copy of updated list of the same.
    • 8. Escalate to the management through through Quality Manager, where resolutions of audit findings are inadequate.
    • 9. Review SOP s as necessary and distribute the same to the concerned departments.
    • 10. Conduct Routine Process Audits
    • 11. Represent QA at operational and cross functional meetings and provide training to technical staff on subjects related to Vimta s management system.
    • 1. To perform QA activities in other departments on need basis and assist QA staff as and when required.
    • 2. To give training forms and initiate training records.
    • 3. To provide documents for self reading to new recruits.
    ,

Keyskills :
qualityquality controlauditingquality assuranceinspectiontechnical staff managementprocess auditsupport servicesstaff managementclinical researchmethod validationvalidation reportscontinuous improvementregulatory requirementsgxpsopforms

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