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Manager - Quality Assurance

5.00 to 10.00 Years   Chennai   16 Mar, 2022
Piramal Glass
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaTesting
EmploymentTypeFull-time

Job Description

    *Responsible for GMP Compliance and batch release of intermediates and API. Accountable for OOS investigation and approval of analytical method transfer/validation documents of products. Review and approval of facility qualification and co-ordinate failure investigation in calibration and preventive maintenance activity in manufacturing facility., *
    1. Strict adherence to cGMP norms and safety rules of the factory
    2. Liaising with external manufacturing site for product technology transfer
    3. Ensure GMP compliance in manufacturing blocks
    4. Batch release of intermediates and APIs.
    5. Approval of Out of Specification investigation report related to intermediates and API followed by tracking and monitoring of CAPA till closure.
    6. Audit readiness and handling audits.
    7. Review and approval of APQR for APIs
    8. Conducting the internal audit in manufacturing blocks
    9. To support material management by vendor evaluation and approvals
    10. Co-ordination with regulatory affairs department for review and approval of change control documents related to facility, process, equipment related to product manufacturing.
    11. Review and approval of qualification document related to process equipment, utility system, facilities and analytical instruments in QC scheduled as per Validation Master Plan.
    12. Investigating deviations related to calibration, preventive maintenance followed by tracking and monitoring of CAPA till closure.
    13. Review and approval of analytical method transfer and validation documents related to intermediates and APIs.
    14. To review and approval of Standard Operating Procedures, BMR, Specifications and Test methods of intermediates and APIs.
    15. Review and approval of QMS documents related to products such as change control, deviation and followed by tracking and monitoring of CAPA till closure
    16. Responsible to review pest control management records of the facility
    17. Responsible for any specific task assigned by Head- Quality
    18. Conducting cGMP training
    19. In my absence, decision related to my area of responsibility will be with Head QA.

Keyskills :
standard operating procedurescontinuous improvement facilitationpest control managementpest controlbatch releaseinternal audit

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