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

Dishman Carbogen Amcis; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Dishman Carbogen Amcis in India seeks a qualified Analyst to execute analytical method validation, verification and transfer, perform stability studies, and support GMP/GLP compliance in API manufacturing. You will operate HPLC, UPLC, GC, GC-HS and dissolution systems, and document activities meticulously.

The role emphasizes strong troubleshooting, data integrity understanding, and collaboration with QA and R&D to drive continuous improvement and compliant analytical processes within a GMP

Qualifications

• 3-5 years of experience in Analytical Method Validation within API/Pharmaceutical industries.
• Hands-on exposure to HPLC, UPLC, GC, GC-HS, Dissolution, and Stability Studies.
• Sound knowledge of GMP, GLP, Data Integrity, Method Validation, and Method Transfer.
• Strong analytical, troubleshooting, and documentation skills.

Responsibilities

• Execute analytical method validation, method verification, and method transfer activities as per approved protocols.
• Perform stability studies and routine analytical evaluations for API and intermediate samples.
• Operate analytical instruments such as HPLC, UPLC, GC, GC-HS, and Dissolution Systems.
• Ensure accurate documentation and adherence to GMP, GLP, and Data Integrity requirements.
• Support laboratory investigations related to OOS, OOT, deviations, and atypical results.
• Prepare analytical reports, protocols, and supporting validation documentation.
• Participate in continuous improvement initiatives and maintain laboratory compliance.

Skills

Analytical Method Validation

GMP

GLP

Data Integrity

Analytical troubleshooting

Documentation

Tools

HPLC

UPLC

GC

GC-HS

Dissolution Systems

Job description

Role & responsibilities

• Execute analytical method validation, method verification, and method transfer activities as per approved protocols.
• Perform stability studies and routine analytical evaluations for API and intermediate samples.
• Operate analytical instruments such as HPLC, UPLC, GC, GC-HS, and Dissolution Systems.
• Ensure accurate documentation and adherence to GMP, GLP, and Data Integrity requirements.
• Support laboratory investigations related to OOS, OOT, deviations, and atypical results.
• Prepare analytical reports, protocols, and supporting validation documentation.
• Participate in continuous improvement initiatives and maintain laboratory compliance.

Preferred candidate profile

• 3-5 years of experience in Analytical Method Validation within API/Pharmaceutical industries.
• Hands-on exposure to HPLC, UPLC, GC, GC-HS, Dissolution, and Stability Studies.
• Sound knowledge of GMP, GLP, Data Integrity, Method Validation, and Method Transfer.
• Strong analytical, troubleshooting, and documentation skills.