Role & responsibilities Candidate should have through knowledge on regulatory guidance, literature search applicable for sterile formulation developments. Responsible for development and execution of complex injectable, suspension, emulsion / ophthalmic formulations solution, suspension, emulsion for regulated market. Should be responsible for review of trials and stability data throughout product development. Candidate should have hands on experience in transfer of technology from R&D to plant / GMP scale. Candidate should be responsible drafting and review of documents like MFC, MPC, BMR/BPR, Stability protocols, specific study protocols / reports, product development report, change controls, item code generations etc.. Responsible for all formulation/ process related CMC documents drafting and review which will be part of regulatory filings. Responsible for execution of process optimization batches, exhibit batches at manufacturing site. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs. Responsible for maintaining lab equipments and ensure lab practices as per defined SOP. Preferred candidate profile Specialization : OSD/Sterile/Ophthalmic for ROW Emerging & Regulated Market. Experience : 2-7 Years Position : Officer / Sr.Officer/Executive Qualification : M.Pharm. Contact : rajiv.farkade@indoco.com and gauri.deo@indoco.com
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