Description

JOB DESCRIPTION

The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the lab's continuous development through training and adherence to SOP

Essential Functions

Candidate should have worked at least 3- 5 years in injectable ARD.
Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc.
Prepare method development report along with tentative analytical method.
Attain method transfer activity.
Method validation like Dissolution, Assay, Related compound and Residual solvents etc.
Preparation TT report
To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory.
Preparation of study protocols with respect to Laboratory.
Development batch stability analysis as per stability protocols
Responsible for COA preparation and release of development sample against TRF.

Additional Responsibilities

Taking responsibility to give training to junior for on job training
Attend technical workshop /seminar and explore new technique and technology at work place

Education

QUALIFICATIONS

Master Degree (MS/MA) M. Sc - Preferred
Master Degree (MS/MA) M. Pharma - Preferred

Experience

Minimum 5 years in injectable

Skills

Documentation & Data Review, Interpretation & Statistical Analysis - Intermediate
Anlytical Method Development & Validation - Intermediate
Good Laboratory Practices (GLP), Data Integrity and Compliance - Advanced
Stability Study Management - Advanced
Good Documentation Practices (GDP) - Intermediate
Electronic Lab Notebook (ELN) Management/LIMS - Advanced
Adapts to organizational growth - Intermediate

Specialized Knowledge: Licenses:

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.

Executive / Senior Executive, Analytical R&D | Method Development Injectable