brand logo

Assistant Manager Verified

Other

Job Description

Roles and Responsibilities:

  • Preparation, review, and compilation of Aseptic Package.
  • Review of Sterilization package.
  • Review of Media fills documents.
  • Evaluation of documents for submission to regulatory authorities.
  • Review of stability protocols and reports.
  • Review of analytical method validation protocols and reports.
  • Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
  • Review and assessment of change control.
  • Compilation and submission of Post Approval Supplement viz. PAS, CBE-0, CBE-30.
  • Preparation, Review, and Submission of Amendments and supplements for the assigned products
  • Preparation, Review, and Submission of response to the Agency s queries for the assigned products
  • Compilation and submission of Global Annual Report.
  • Review of Process Validation Protocol, hold time study protocols and reports
  • Review of Product Development Report
  • Review of executed documents including executed BMR, and Certificate of Analysis to ensure compliance with regulatory requirements
  • Review of batch records for solid oral dosage form

Job Summary

  • Location
    Indore,Madhya Pradesh
  • Job Type
    Full-Time
  • Salary (in LPA)
    ₹ - ₹
  • Date Posted

    2022-08-03 18:39:01

  • Required experience

    5years - 10years

Skills Requred

  • Analytics skills
  • Critical Thinking
  • Email
  • Team Handling
  • Assessment
  • Logical Thinking
  • Communication
  • Relationship Building
  • Problem Solving Skills