Department: Quality Assurance
Job Location: Inventia Healthcare Ltd., Ambernath
Qualification: B. Pharma/M. Pharma
Experience: 2 to 4 Years
Job Profile –
1. Review of the documents relevant to scale-up and Exhibit batches execution like
BMR, BPR, Protocols, scale up report.
2. Preparation / Review of protocols and reports for Process validation and hold time studies
3. Provide submission related documents to RA for different regulated markets such as US, EU and other ROW countries
4. To co-ordinate with cross functional team like site manufacturing team
(Production, QA and QC), R & D, RA, TT etc. to meet aggressive timeline for
regulatory submission to meet business priorities.
5. Monitors exhibit batches for online recording & resolution of observations
6. To evaluate and respond to deficiency of Drug Product by regulatory agencies
7. Good communication skill with cross functional plant team and technical
document knowledge.
email me your profile on anuja.nirgun@inventia.com
