QA will lead and oversee the entire QA function manufacturing facility,includes both General Injectable and General OSD units. ensuring compliance, USFDA, ensuring compliance to cGMP, cross-functional collaboration quality-driven site operations. Required Candidate profile Site Quality Leadership, Compliance Management, (QMS) Ownership, Cross-functional Collaboration, Batch Release and Product Quality Oversight, Training and Development, Qualifications & Validations
Preparation& Review of stability study protocols,reports, summery sheet for all the products ( General Injectable &OSD) cross functional with R &D,QA,Prodcution etc. ,GMP/SOP training QC Activities ADL/Oncology & General Block Qualification/issuance
Screening of new products. Patent Filing in India and US. Strategic planning for the launch of new product including first generic launches. Indian Patent application & PCT application. Required Candidate profile Patent/ Patent Application's Opposition drafting & preparing documents for E- filing Patent Prosecution in India & US Review Monthly Patent update & Tracking for concerned Patents/ Patent applications
Convincing customer through Valid IP understanding and arguments Screening of new products. Strategic planning for the launch of new product including first generic launches Indian Patent application & PCT application. Required Candidate profile Review Monthly Patent update & Tracking for concerned Patents/ Patent applications. Reply to office actions & Indian Patent application & PCT application Attending patent hearing at respective IPO
End-to-end financial operations including SAP-based accounting, inventory and cost control, balance sheet finalization, and ensuring statutory compliance. The ideal candidate must have a strong command over SAP (FICO and Product Costing modules
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