Deputy Manager - Section Head - Quality Control - AMV / AMT

Job Description

Relevant Experience: QC/R&D exposure of 14 to 16 Years of experience from Regulatory Approved Plant (USFDA/MHRA) of OSD formulation related. Experienced Analytical Method Validation and Transfer Specialist. Candidate should have a strong background in ICH Q2, Analytical Method Validation, and Method Transfer for the US and European markets. and will play a critical role in ensuring regulatory compliance and efficient operation of analytical processes in accordance with global standards. Key Responsibilities: Lead Analytical Method Validation (ICH Q2) and Analytical Method Transfer activities for both the US and European markets. Ensure compliance with ICH Guidelines, Quality Risk Management (QRM), Nitrosamine Impurity, Elemental Impurity Guidelines, and other regulatory requirements. Demonstrate a deep understanding of 21 CFR Part 11, EU Annex 11, and GAMP5 for Computerized System Validation. Manage and maintain key QC instruments, including HPLC, GC, UV, FTIR, KF Autotitrators, and Malvern Particle Size Analyzers. Participate in Quality Management System (QMS) investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), and Lab Incidents. Review and manage QC analytical records using electronic LIMS systems, such as Labware LIMS.