Roles and Responsibilities
- 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
Skills highlighted with ‘‘ are preferred keyskills
UG:B.Pharma in Any Specialization
PG:M.Pharma in Any Specialization
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