Assistant Manager

From 5 to 10 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

Job Summary

  • Preparation, review, and compilation of Aseptic Package.
  • Review of Sterilization package.
  • Review of Media fill 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 andReports
  • Review of Product Development Report
  • Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement
  • Review of batch records for solid oral dosage form




Key Skills
Skills highlighted with ‘‘ are preferred keyskills

Education

UG:B.Pharma in Any Specialization

PG:M.Pharma in Any Specialization

Company Profile

HR Services

Hr Services
Company Info
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View Contact Details+

Recruiter Name:Arpana

Contact Company:HR Services

Telephone:9041005161

Website:http://jobs.hrsindia.co.in

Salary:

Not Disclosed by Recruiter

Functional Area:

Legal & Regulatory

Role Category:

Corporate Affairs

Role:

Regulatory Affairs Compliance

Employment Type:

Full Time, Permanent