Unichem Laboratories Limited
Location
Mumbai | India
Job description
RESPONSIBILITIES
R&D Sourcing Source vendors for API, Excipient for new formulation project for all market including US and EU Documentation for ADNA filing, open part DMF from API vendors. Collect all the required documentation for initial evaluation from new/alternate vendor. Co-ordinate with Legal team to initiate CDA to disclose the confidential data open part DMF from outsource API vendors. Dossier extension to other market Co-ordinate with internal team (RA, Project management etc.) & arrange required documentation part from respective vendors for dossier extension and submission. Technical queries Arrange responses for open part DMF, technical queries & deficiencies wrt API, Excipient items. Procurement Arrange API, excipient for R&D to perform R&D development trial upto validation batches. Procurement of working /reference & impurities standards for R&D & all formulation units Process import service & RLD items POs related to R&D. QA Documentation Arrange VQ & other documents of API & excipients to maintain AVL at plant level, dossier filing etc. Disposal of Non-moving/Near Expiry Inventory Arrange for disposal of Non-Moving/Near Expiry raw materials. DESIRED SKILLS Experience in sourcing of API, excipient for new formulation projects of regulatory and ROW markets Good knowledge of regulatory documentation Excellent negotiation skills and interpersonal skills Ability to work in a team environment. Willingness to work on diverse projects/areas. Proficient in word/excel and PowerPoint.Job tags
Salary
