5 - 9 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: As a member of the team at Amneal, you will be responsible for preparing, reviewing, and approving Certificate of Analysis (COA) and stability protocols, reports, and summary reports. You will also play a key role in justifying the reduction of tests for various types of material and testing as well as handling item codification. Your expertise in analytical documentation, ICH Guidelines, Stability Management, QMS Automation System, and US Guidelines will be crucial for success in this role. Key Responsibilities: - Prepare, review, and approve Certificate of Analysis (COA) - Review and approve stability protocols, reports, and summary reports - Justify reduction of tests for various testing categories - Prepare and review specification/Method of analysis - Initiate and evaluate Change control - Review vendor qualification documents - Handle item codification Qualifications Required: - B- Pharmacy degree - Proficiency in Analytical documentation, ICH Guidelines, Stability Management, QMS Automation System, and US Guidelines Additional Company Details: Amneal is committed to being an equal opportunity employer, valuing diversity and inclusion in the workplace. The Human Resources team plays a crucial role in partnering with all aspects of the organization to drive success through effective people management. The team's key roles include executive specialists, audit compliance, facilitators supporting various areas, consultants providing expert advice, and service providers ensuring awareness of developments impacting employment matters.,

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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