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Assoc, Quality Assurance - IPQA

1.00 to 4.00 Years   Ahmedabad   27 May, 2023
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Assoc, Quality Assurance - IPQA
    • To take instructions from Supervisor to manage shift activity. To verify raw material at the time of dispensing against BMR or Standard Format approve the process step.
    • To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and if any deviation or abnormal observation in terms of noncompliance to Good Manufacturing Practice (GMP) observed, bring to the notice of Supervisor.
    • To ensure that finished product samples are collected from defined location after that perform visual inspection from authorized visual inspector and perform leak test and submit it to QC & Micro.
    • To help Supervisor in preparation, review, implement and update SOP s according to current regulations systems.
    • To provide line-clearance for routine manufacturing activity and dispensing activity, monitor each line & sample collection at regular interval.
    • To carry out stagewise BMR review for batch execution compliance.
    • To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month.
    • To collect the data related to CPPs/ CQAs and shall perform data analysisy. Report any abnormality gap to supervisor /QA Head and take corrective and preventive action in coordination with respective functions.
    • To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users. Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required. To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review and approval.
    • To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook.
    • To perform periodic Clean room inspection and ensure its compliance. In case of any product complaints or non-conformities provide support to Supervisor in investigation.
    • To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per instruction of Supervisor. Material A.R.No. Stock Blockage or Un-blockage in System.
    • To give non-compliance reports to the respective departments in case of internal quality audits and report it to Supervisor and QA Head.
    • To communicate about any failure or abnormal notification to Supervisor & QA Head for their attention and seeking for the solution.
    • To seek area of improvement from QA Head and implement action plan.
    ,

Keyskills :
quality management systemquality auditaccess controlrisk assessmentquality assurancepreventive actionimpact assessmentvisual inspectionmanagement systemquality managementcorrective

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