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5.0 - 10.0 years
4 - 9 Lacs
thane
Work from Office
Role & responsibilities To perform method development and validation for Extractable and Leachables, Nitrosamine and another specific impurity by LCMS (GCMS and ICPMS added advantage) To prepare analytical method validation protocols for various validation by ICP-MS, GC-MS and LC-MS To prepare Technology transfer Protocol and reports. Technology transfer of LCMS method (leachable content, NDSRI and Genotoxic Impurity). Responsible for calibration of analytical pH meter, Balance, ICP-MS, LCMS and GCMS instruments. Responsible for preparation AMDR, Validation Reports, E&L and NDSRI reports. Responsible for ensuring compliance with GLP, Safety and Environment requirements. Participate in traini...
Posted 4 hours ago
3.0 - 5.0 years
1 - 5 Lacs
Hyderabad
Work from Office
Dear All, We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry. Responsibilities: Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS). Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale. Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations. Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations. Drive nitrosamine risk assessments for APIs...
Posted 3 months ago
15.0 - 24.0 years
25 - 35 Lacs
Navi Mumbai
Work from Office
Job Title: General Manager Analytical Laboratory (Extractables & Leachables and Nitrosamine Impurities) Location: Rabale, Navi Mumbai Company: Fusion Scientific Laboratories Experience: 15+ Years About Fusion Scientific Laboratories: Fusion Scientific Laboratories is a USFDA and EMA-accredited laboratory based in Rabale, Navi Mumbai. We provide specialized services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services to leading pharmaceutical clients worldwide. With a robust focus on regulatory compliance and scientific excellence, Fusion Scientific delivers innovative, high-quality solutions to meet evolving industry needs. Position Overview: We are loo...
Posted 4 months ago
3.0 - 8.0 years
2 - 5 Lacs
ahmedabad
Work from Office
Unison Pharmaceuticals Pvt Ltd is urgently seeking talented ADL Scientists for LCMS - Nitrosamine Impurities at our dedicated R&D Center based at Changodar (Ahmedabad). About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. WE ARE EXPANDING!!! You a...
Posted Date not available
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