Senior Officer, Analytical R&D Injectable | Method Validation

Amneal India; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Amneal India is seeking a qualified professional to lead and review method validation for assays, dissolution, related compounds, and residual solvents on new projects using HPLC, UV, IC, GC, ICP-MS and AAS. The role includes preparing validation protocols for API and finished products, STPs, specifications, and ensuring successful method transfers.

You will coordinate with ARD-Development, QA and QC, maintain training records, and drive timely completion of validation activities.

Qualifications

• Experience in method validation for assays, dissolution, related compounds and residual solvents.
• Proficiency with multiple analytical instruments used in validation.
• Knowledge of API and finished product validation requirements.

Responsibilities

• Perform and review method validation for assays, dissolution, related compounds, and residual solvents on new projects using HPLC, UV, IC, GC, ICP-MS and AAS.
• Prepare method validation/verification protocols for API and finished product (HPLC, GC, IC, AAS).
• Prepare STPs and specifications in line with validation protocols.
• Review method transfer reports and address queries on assay, dissolution, related compounds, elemental analysis, and residual solvents.
• Maintain self-training records and ensure continuous professional development.
• Coordinate with ARD-Development, QA and QC and ensure timely completion of validation, verification and transfers.
• Accept additional duties as assigned by the Head of Department.

Skills

Method validation

Quality assurance coordination

Validation review

Education

Master’s degree MSc/MA

M. Pharm (preferred)

Tools

HPLC

UV

IC

GC

ICP-MS

AAS

Job description

• - Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC,UV, IC ,GC,ICP MS and AAS etc.
• 2. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.
• 3. Preparation of STPs and Specifications as per method validation protocol.
• 4. Check the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound, Elemental analysis and Residual solvents etc.
• 5. To attain and complete self-training record.
• 6.To coordinate with ARD-Development, QA and QC.
• 7. Ensure timely completion of validation/verification and method transfer.

Additional Responsibilities:

• - Activities other than the defined in the Job Responsibility are to be done, as per the requirement of HOD

Education:

• - Master Degree (MS/MA) M. Sc. - Required
• - M. Pharm M. Pharm - Preferred

Experience:

• - 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: