Senior Officer Analytical RandD Injectable Method Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a qualified professional to perform and review method validation across assays, dissolution, related compounds, and residual solvents using instruments like HPLC, UV, IC, GC, ICP MS and AAS. The role includes protocol preparation, method transfer checks, and coordination with QA/QC. The candidate should hold a Master’s degree (MS/MA or M.

Sc.) with 5+ years of experience in pharma validation; M. Pharm is a plus.

Qualifications

• Master's degree in a relevant field is required.
• Candidate should have 5+ years of experience in validation/verification in pharma.
• Experience with analytical instrumentation and method transfer.

Responsibilities

• Perform and review method validation for assays, dissolution, related compounds, and residual solvents.
• Prepare validation/verification protocols for APIs and finished products.
• Prepare STPs and specifications per validation protocol.
• Check method transfer protocols/reports and resolve related queries.
• Maintain self-training records and ensure timely completion of validation activities.
• Coordinate with ARD-Development, QA and QC.
• Ensure timely completion of validation/verification and method transfer.

Skills

Method validation

Analytical testing

Quality assurance

Coordination with departments

Education

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

M. Pharm - Preferred

Tools

HPLC

UV

IC

GC

ICP MS

AAS

Job description

Job Description:

1. 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. 2. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.
3. 3. Preparation of STPs and Specifications as per method validation protocol.
4. 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. 5. To attain and complete self-training record.
6. 6.To coordinate with ARD-Development, QA and QC.
7. 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

Qualifications

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

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

TheHuman Resources teampartners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key roles that the Human Resources team performs:

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Requirements: