Experience : 3-6 years
Qualification: M.Sc. / M.Pharm /
Job Description
- Compilation of eCTD format & review of dossier (ANDA, MAA, ANDS) including technical data package.
- Review of Batch records, specification, art work and packaging material, analytical method validation documents, development documents, PDR & labeling.
- Coordination with R&D in evaluating and finalizing QbD elements at different stages of product development. Write high quality deficiency response to regulatory authorities.
- Send Resumes to: ruchi.panjwani@biocon.com
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