Sava Healthcare Limited Esteemed in 2003, we at "SAVA" are committed to make life "Feel Good" with our range of healthcare products for Humans and Veterinary. SAVA offers services that are benchmark of 'Superlative Quality, Enviable Economy' which are built on the sturdy pillars of financial solidarity, stability, reliability, operational expertise, infrastructure, technology and revolutionary business strategy and execution.
Post : QA- DRA
Job Description
1. Dossier preparation for ACTD, CTD Countries.
2. Support in Preparation of Dossier for ACTD, CTD Countries.
3. Organizing the completion of documentation cell for faster retrieval of documents.
4. Organizing of soft copies pertaining to DRA in the data base with daily updation.
5. Coordination with R&D, Production and DRA, for the DRA samples as and when requires.
6. Review of batch records, specifications, COAs, Process validation Reports, MFRs.
7. Compilation of ACTD, CTD, regional format and Country specific product registration dossier for pharmaceutical products.
8. Preparation and Review of technical documents required to enclose for product registration.
9. Application of product permission (PP) and certificate of pharmaceutical product (COPP) in FDC and WHO product inclusion in CDSCO.
10. Initiation and review of drug product artworks like Package Insert, PIL, SmPC, Label and Carton for regulatory submission (Country specific as well as general export artworks).
11. Working as responsible team member and coordinating all activities so as to deliver the target in given time limits.
Additional Information:
Education : B.Pharm
Experience : 4 years
Location : Surendranagar
Salary: INR 50,000 - 3,00,000 P.A.
Indusrty Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 29th November, 2017
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