Analytical Method Validation

2 days ago


Nimrana RJ IN Indus Pharma Pvt. Ltd. Full time

Plan execute and document analytical method validation accuracy precision specificity linearity robustness LOD LOQ etc for raw materials in-process samples finished products and cleaning validation Review and approve validation protocols and reports in compliance with ICH Q2 R1 USP and other regulatory requirements Ensure all AMV activities meet GMP GLP and cGMP guidelines Coordinate with R D QA and Production teams for smooth tech transfer and validation support Troubleshoot analytical method issues and recommend improvements or revalidations when necessary Maintain and calibrate analytical instruments e g HPLC GC UV-Vis FTIR Prepare for and participate in regulatory inspections and internal audits Train and mentor junior QC staff on method validation procedures and regulatory expectations Ensure all documentation is complete accurate and archived as per SOPs Note Joining Required Immediate Joiner Required Educational Qualification B Pharm M Pharm MSc Analytical Chemistry or equivalent Qualifications and Experience Education B Pharm M Pharm MSc Analytical Chemistry or equivalent Experience Minimum 5-7 years in QC with at least 2-3 years specifically in AMV for sterile injectable formulations Strong hands-on experience with HPLC GC UV and other analytical techniques Job Types Full-time Permanent Pay From 20 000 00 per month Benefits Food provided Paid sick time Schedule Weekend availability Supplemental Pay Overtime pay Yearly bonus Work Location In person



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