0.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

Job Description Job Description Prepare, Review and Approval of COA. Review and Approval of stability protocols, reports, and summary reports. Prepare justification for reduction of tests for Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing; Microbial testing. Prepare and review of specification/Method of analysis. Initiation, evaluation of Change control. Review of vendor qualification documents. Handling of item codification. Technical Skill Required Analytical documentation : Advanced ICH Guidelines : Advanced Stability Management : Advanced QMS Automation System : Intermediate US Guidelines : Advanced Qualification...

Posted 1 week ago

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Executive, QMS Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

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 v...

Posted 1 week ago

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