Scientist-Chemistry-Analytical

**Responsibilities & Duties: ** ## 1.1 Compliance and Quality * Perform all activities in compliance with GxP requirements. * Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines. * Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS. ## 1.2 Analytical Development and Troubleshooting * Troubleshoot analytical issues related to methods and instrumentation. * Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support. * Develop GTI impurity methods using LC-MS and GC-MS. * Assess existing data packages, evaluate feasibility, and recommend remediation where needed. * Has strong knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems, along with expertise in writing non-laboratory, paper-based assessment reports for packaging commodities. ## 1.3 Documentation, Governance, and Review * Work with Quality Assurance and cross-functional teams to support consistent and disciplined execution of the LIR/ER/CAPA quality system, ensuring assigned tasks are complete and thorough. * Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable. * Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making. ## 1.4 Cross-Functional Coordination * Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making. **Educational Qualification & Work Experience:** **Preferred Qualification:** Master's in chemistry/pharmacy/Ph.D **Type of Experience:** Brings 5–7 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachable studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, support