BriefCase
BriefCase

Executive/ Sr. Executive- Qa(qms) Job in Leben Life Sciences

Executive/ Sr. Executive- Qa(qms)

Leben Life Sciences 4+ weeks ago
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Job Summary

Minimum experience required in this position:

5+ years

Description:

Roles & Responsibilities :-

  • Preparing and reviewing Site Master File, Validation Master Plan, Master Batch Records, Departmental Manual, and data integrity policy.
  • Executing and compiling equipment qualification, HVAC qualification, facility qualification, temperature mapping of areas.
  • Performing cleaning validation, process validation, and hold time study of drug products.
  • Preparing, Reviewing & Executing Water System and Compressed air Protocol.
  • Ensuring adherence to quality standards & maintaining all the related documents conducting inspections at various stages to ensure safety & quality specifications are met without any slippages.
  • Steering the implementation of cGMP for all operational activities.
  • Conducting Audits and ensuring compliance and audit readiness reviewing analytical report.
  • Imparting Training, conducting online on job as well as classroom training for cGMP, cGDP to support subordinates.
  • Participating in Internal Audits to ensure quality in other departments like Production, Warehouse, Engineering & QC and so on.
  • Addressing market compliances, deviation, CAPA, and change Finalizing Artwork and Specification for Printed Packaging Materials.
  • Checking and preparing all the dimensions of art work specification for Printed Packaging Material
  • Checking and preparing all the dimensions of art work and send it to pack pilot for approval
  • Participating on PLC/CSV validation activities
  • Reviewing of Batch Manufacturing Records and bill of material
  • Preparing and reviewing of Annual Product Quality Review.
  • Reviewing Instructions, Packaging configurations Artwork, Shade cards, Specimen printed packing material Specifications, Standard Test Procedures, Record of Analysis Report, General Analytical Method and Stability Protocol
  • Following instructions given by HOD.

    • Highest Qualification :-

    B.Pharm / M.Pharm / B.Sc / M.Sc

    Location :-

    Akola
    Experience Required :

    Minimum 5 Years

    Vacancy :

    2 - 4 Hires

    Apply Now
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