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QA Reviewer

4.00 to 7.00 Years   Bangalore   30 Nov, 2022
Syngene International Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other SoftwareQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    JOB PURPOSE (Briefly describe the objectives of the job):Review of Quality Documents and Compliance KEY RESPONSIBILITIES :
    • Review and authorized for Approval of blank ODS, issuance of the copy from master ODS for lab execution and reconciliation of analytical package after completion.
    • Review of OOS, OOT and Deviations.
    • Review of Protocols and Reports for analytical activities.
    • Monitoring of samples receipt and inception, incubation, labeling, pull out of samples as per schedule
    • Preparation of SOP for Quality Assurance and ensuring the timely revision of the same.
    • Review of Qualification Protocols and Reports (URS/IQ/OQ/PQ/DQ)
    • Deriving (wherever applicable) and monitoring of CAPA implemented for its effectiveness
    • Monitoring of stability study conducted in accordance with the regulatory requirement
    EDUCATIONAL QUALIFICATION:M.Sc. or Equivalent WORK EXPERIENCE:4 to 7 years TECHNICAL /FUNCTIONAL SKILL: cGMP, compliance and Knowledge on Analytical investigations BEHAVIORAL/MANAGERIAL SKILLS: Team player, Time management OTHER JOB REQUIREMENTS: Based on the requirement other job responsibilities to be fulfilled,

Keyskills :
quality assurancesopoosootodscapaassuranceprotocolscomplianceregulatorymonitoringanalyticalincubationreconciliationGxPChange ControlQuality AuditingCorrective

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