IRA (Documentation)
Job Description:
Job profile.
1. Dossier preparation and filling for product registration in International Regulatory bodies.
2. Query replies to International regulatory authority for the dossier for product registration.
3. Documents follow up with Production,QA and QC dept required for Dossier preparation.
4. Regulatory Samples follow up for the product registration along with dossiers filling.
5. Product finalization with clients as per export market requirement.
6. Quotation of the products .
7. Audits preparation and planning for International Regulatory bodies .
8. Development of export business in new countries where Reliance accreditation and facilities are suitable i.e WHO GMP.
9. Co-Ordination and follow up with QA,QC and Production dept. for the Technical documents and queries required for export market.
10. Country specific artworks.
11. Package insert
12. Co ordination with purchase dept for Material prices to finalize the rates with the clients.
13. Preparation for Draft label for export product permission application.
14. Co-ordination for govt. documents such as permission, COPP,FSC etc.
15. Handling of market complaints for the commercial orders regarding the quality.
16. Regulatory Samples follow up for the product registration along with dossiers filling.
Company Profile
"Company is leading and modern manufacturing unit of Pharmaceutical products with specialization in the Neuro psychiatry and have attained other latest molecules in the same segment under ISO9001:2015 & WHO-GMP certified Company," asserts the CEO of the company.The plant has big capacity of production with Modern Machineries which compiles WHO-GMP. The production is managed by well experienced technical staff to maintain best quality of products.company holds an impressive list of clients which include leading distributors, stockist, Government institutions, hospitals, and nursing homes which are repeatedly patronising company specialties. Some of the well-known clients include Railways, Defenses, Municipal Corporation.Company has started to expand its Export business in various countries as Nepal, Mauritius, Libya, Jamaica, Malawi, Somalia, South Sudan, Iraq, Yemen, Kenya and Belarus.
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