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QA Coordinator

2.00 to 5.00 Years   Chennai   07 Jun, 2022
West Pharmaceutical Services
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    1. Responsible for the commercial (human use) and R&D (Not for Human Use) batch release activities including review and approval of the finished Device History Record documentation and Certificate of Compliance issuing against an established checklist
    2. Responsible to review and approve GAMMA/ EtO sterilization documentation, LAL (Endotoxin) test documentation against an established checklist
    3. Responsible to review and approve of graphics artwork for Tyvek, Labels and relevant cartons against an established checklist
    4. Responsible to approve production/R&D work orders in ERP
    5. Responsible to review and approve of samples/R&D (not for human use) batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing against an established checklist
    6. Initiate Nonconforming Product in ERP related to finished batch release and sterilization processes
    7. Support preparations for periodical management reviews
    8. Participation in external audits (notified body and customers)
    9. Write and update quality system procedures
    10. Support QA dept activities- customer complaints, QA monthly report, KPIs, etc.
    ,

Keyskills :

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