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Senior Executive / Asst Manager

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

2 - 7 years

6 - 10 Lacs

Ahmedabad

Posted:1 month ago| Platform:

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Skills Required

USFDA QC Quality standards Senior Executive Manager Quality Control Information management GMP Management MHRA Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Create and manage Quality Control (QC) master data in the Laboratory Information Management System (LIMS), including product specifications, test methods, and sampling plans. Ensure the accuracy, completeness, and compliance of master data with regulatory requirements and internal SOPs. Perform self-review and coordinate for Level 2 review and approval. Collaborate with QC, QA, IT, and other relevant departments to gather required documents and inputs for master creation and updates. Manage master data changes in line with approved change controls, ensuring timely and compliant updates. Troubleshoot and resolve data-related issues in LIMS, coordinating with IT or vendors when required. Maintain up-to-date documentation of master data changes and support audits by providing necessary LIMS records. Ensure all activities adhere to GMP, regulatory guidelines (like USFDA, MHRA, WHO), and internal quality standards.

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AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

www.amneal.com

Pharmaceutical Manufacturing

Bridgewater New Jersey

5001-10000 Employees

14 Jobs

Key People

Chirag Patel

Co-CEO
Shyam Patel

Co-CEO
Jeffrey T. Arokiasamy

Senior Vice President of Business Development

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Senior Executive / Asst Manager