Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts.
Post : Executive/ Sr. Executive
Department : Development Quality Assurance (Formulation R&D)
Qualification : Masters (Pharmaceutical Chemistry/ Quality Assurance / Analytical Chemistry / Organic Chemistry) with 4 - 7 years' experience.
Job Location : Bangalore
Key Responsibilities
• Review analytical documents from early & late-stage development, technology transfers to pilot production across CMOs.
• Review analytical documentation such as protocols, SOPs, test methods, data, ROAs, COAs and reports through collaboration with ARD and QC scientists to achieve the highest quality from technical and compliance perspectives.
• Review development documents for regulatory submissions, including pre-formulation studies, analytical method development/validation, stability protocols & reports.
• Responsible for investigations against laboratory Incidents, OOS, OOT encountered with aim of root cause identification and CAPA.
• Review data for specifications proposals, test methods and Master formula cards for finished products.
• Responsible for maintaining and tracking internal departmental documents and reports.
Interested candidates may send their updated resumes with subject line Internal Application for Executive/ Sr. Executive - Development Quality Assurance (Formulation R&D)' to preeti_s@aurigene.com
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