Senior Officer, Analytical R&D Injectable | Method Validation

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a scientist to perform and review method validation and transfer for API and finished products. The role involves preparing validation protocols and ensuring timely completion, coordinating with QA/QC/ARD-Development, and maintaining self-training records.

The candidate should have a Master’s degree and 5+ years of experience in pharma method validation. The position requires proficiency with HPLC, GC, IC, UV, ICP MS and AAS instruments, and a willingness to

Qualifications

• Master degree in science or related field is required.

Responsibilities

• Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc.

Education

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

M. Pharm 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

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