Executive / Senior Executive - QC Analytical Method Validation (AMV)

Dishman Carbogen Amcis; Ahmedabad District; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Dishman Carbogen Amcis in Ahmedabad is seeking a seasoned professional to plan and execute analytical method validation, verification, and transfer activities in line with regulatory guidelines.

The role involves handling stability studies, data interpretation, and instrument troubleshooting for HPLC, UPLC, GC, GC-MS, GC-HS, and dissolution systems, with emphasis on GMP/GLP compliance and CAPA-driven investigations.

Qualifications

• 5-8 years of experience in Analytical Method Validation within API/Pharmaceutical industries.
• Strong expertise in Method Validation, Method Transfer, Stability Studies, and Data Integrity compliance.
• Hands-on experience with HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
• Exposure to laboratory investigations, CAPA, regulatory audits, and compliance activities.

Responsabilités

• Plan and execute analytical method validation, verification, and method transfer activities per regulatory guidelines.
• Independently handle stability studies, data interpretation, and analytical trending.
• Operate and troubleshoot advanced analytical instruments including HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
• Review analytical data, protocols, reports, and laboratory documentation.
• Lead laboratory investigations related to OOS, OOT, deviations, and CAPA implementation.
• Ensure GMP, GLP, and Data Integrity compliance across analytical activities.
• Coordinate with QA, Production, Regulatory Affairs, and cross-functional teams to ensure timely project completion.
• Drive continuous improvement initiatives and support regulatory inspections/audits.

Connaissances

Analytical skills

Communication

Stakeholder management

Data interpretation

Outils

HPLC

UPLC

GC

GC-MS

GC-HS

Dissolution Systems

Description du poste

Role & responsibilities

• Plan and execute analytical method validation, verification, and method transfer activities in compliance with regulatory guidelines.
• Independently handle stability studies, data interpretation, and analytical trending.
• Operate and troubleshoot advanced analytical instruments including HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
• Review analytical data, protocols, reports, and laboratory documentation.
• Lead laboratory investigations related to OOS, OOT, deviations, and CAPA implementation.
• Ensure GMP, GLP, and Data Integrity compliance across analytical activities.
• Coordinate with QA, Production, Regulatory Affairs, and cross-functional teams to ensure timely project completion.
• Drive continuous improvement initiatives and support regulatory inspections/audits.

Preferred candidate profile

• 5-8 years of experience in Analytical Method Validation within API/Pharmaceutical industries.
• Strong expertise in Method Validation, Method Transfer, Stability Studies, and Data Integrity compliance.
• Hands-on experience with HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
• Exposure to laboratory investigations, CAPA, regulatory audits, and compliance activities.
• Strong analytical, communication, and stakeholder management skills.