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Analytical Quality Assurance

4.00 to 7.00 Years   Mysore   17 Jan, 2024
Avani Consulting
Job LocationMysore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaProduction
EmploymentTypeFull-time

Job Description

    Greetings from Avani consulting.!We are hiring for the Analytical Quality Assurance profile for API Manufacturing company in Mysore.Job description:
    • Review of analytical data generated during at Quality control laboratory different analytical testing
    • Review of batch release documentation
    • Review of analytical protocols for analytical method validation, method transfer and process validation
    • Review of analytical data release docket
    • Review audit trails in Empower software and other standalone instruments
    • Review of daily calibration data generated at laboratory Internal audit of laboratory
    • Preparation of protocols for analytical activities Review of Quality control SOPs
    • Exposure to regulatory inspections like USFDA, EDQM
    • Conduct risk assessment for analytical activities and enforce SOPs
    • Knowledge and hands on experience on QMS documentation like change control, lab incidents, OOS, OOT, investigations.
    • Preparation and review of laboratory incidents, OOS and OOT reports.
    • Awareness of 21 CFR part 11 requirements including User Management Policies, audit trail review etc.
    • Review of laboratory computer system validations as per GAMP guideline.
    • Hands on experience in sophisticated instruments like HPLC, GC, GC-MS, Malvern, TOC for testing of sample for Purity, impurity etc.
    • Review of Instrument Qualification documents in line with regulatory requirements
    • Preparation and review of Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
    • Writing analytical specifications using current pharmacopoeias and reviewing existing analytical specifications.
    • Supporting all QC activities for review and timely release of test reports.
    • Experience to work on Quality management software like SAP, Track wise, LIMS etc. will be added advantage
    • Candidate should possess managerial skills and team building capability.
    Kindly share resumes to hidden_email or whatsapp@hidden_mobileThanks & RegardsJyotsnaHR RecruiterAvani Consultinghidden_email

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