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Require for the Assistant Manager - Quality Assurance

4.00 to 6.00 Years   Chennai, Hyderabad, Kolkata   28 Jun, 2022
Sygene
Job LocationChennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

        1. Review of method validation analytical raw data generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification.
        2. Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
        3. Review of Outsourced analytical report
        4. Review of logbooks with respect to all activity performed in the lab.
        5. Responsible for taking any other job allocated by Department Head / Department In charge.
        6. Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document
        7. Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents.
        8. Review the documents for completeness, compliance to Good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable.
        9. Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out.
        10. Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable.
        11. Responsible to ensure review and approval of analytical calibration reports and Review of method validation protocol and method transfer protocols.
        12. Involving in investigation of Laboratory Incidence / OOS / OOT and ensuring investigation is performed as per procedure.
        13. In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory.
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Keyskills :
tatsalesbalancemisstandard operating procedurebankingmethod transfer

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