Senior Officer, Analytical R&D Injectable | Method Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; Presencial; INR 600 000 - 1 000 000; Tempo integral

Resumo da oferta

Amneal Pharmaceuticals LLC in Ahmedabad, India, seeks a Method Validation Specialist to perform validation/verification for assays like HPLC, GC and IC, including related compounds and residual solvents. You will prepare validation protocols, STPs and Specifications, and coordinate with ARD-Development, QA and QC to ensure timely completion.

The ideal candidate holds a Master’s degree (MS/MA, MSc) with 5+ years in method validation and transfer, and is proficient in regulatory-compliant

Qualificações

• Master's degree in a relevant field is required.
• Experience with method validation/verification for API and finished products.

Responsabilidades

• Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents for new projects.
• Prepare method validation/verification protocols (API and finish product).
• Prepare STPs and Specifications as per protocol.
• Coordinate with ARD-Development, QA and QC to ensure timely completion of validation/transfer.

Conhecimentos

HPLC

UV

IC

GC

ICP MS

AAS

Formação académica

Master Degree (MS/MA) M. Sc.

M. Pharm

Descrição da oferta de emprego

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.
• Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.
• Preparation of STPs and Specifications as per method validation protocol.
• Check the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound, Elemental analysis and Residual solvents etc.
• To attain and complete self-training record.
• To coordinate with ARD-Development, QA and QC.
• 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

QUALIFICATIONS

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

Experience

• 5 years or more in 5 - 8 Years

About Us

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.

About The Team

The Human Resources team partners 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.