Analytical QA (AQA)

☞ Dr. Reddy’s Laboratories

看过: 101

更新日: 30-05-2024

位置: Baddi Himachal Pradesh

类别: 质量保证/质量控制

行业: Pharmaceutical Manufacturing

水平: Director

工作类型: Full-time

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工作内容

Location : Baddi, Himachal Pradesh, India

Reporting to : Section Head - Quality Control

Role: This role of AQA requires experience in Analytical QA or QC with 10+ years in QC Compliance and Team Leading

Job Title : Team Leader- AQA

Job Description

  • 1.0 Responsible for review, investigation, trending and closure of OOS, OOT, and Incidents as per SOP.
  • 2.0 Responsible for review and approval of Standard Operating procedures and systems.
  • 3.0 Responsible for review of Qualification and calibration data of all analytical instruments and equipment’s.
  • 4.0 Responsible for review of Finish products, In-process, RM, PM and Stability analytical reports.
  • 5.0Responsible for compliance of Method Transfer / Method Validation / Method Verification reports.
  • 6.0 Responsible for level-2 signoff activity on Empower-2 system.
  • 7.0 Responsibility for approval of Record of Analysis.
  • 8.0 Responsible to ensure the GLP/GDP in quality control.
  • 9.0 Responsible for review of analytical miscellaneous activities protocols and reports.
  • 10.0 Responsible for UD of Spec-check & ’VLOC’ material of QC
  • 11.0 Responsible for Control on UD transection (QA32) usmg T-code, ZQM_Authority.

    • Mandatory Skills

    Investigation, Deep knowledge of Quality control functions, Chromatography, OOS & OOT Investigation

    Tags

    OOS & OOT Investigation

    Years Of Experience

    10 to 12 Years

    Education/Qualification

    M Sc

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    最后期限: 14-07-2024

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