12 Aug
|
Endo Pharmaceuticals
|
Chennai
12 Aug
Endo Pharmaceuticals
Chennai
Job Description Summary
Experienced Analytical/Quality Control Analyst with 3 5 years of hands-on experience in an FDA-regulated pharmaceutical setting. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Robust understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.
Job Description
Perform routine and stability sample analysis as per approved specifications and test methods
Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
Review and document analytical data in compliance with cGMP and data integrity principles
Investigate OOS/OOT results and support deviation and CAPA activities
Ensure compliance with FDA, cGMP, and GLP requirements
Prepare and review analytical reports, protocols, and SOPs
Participate in method transfer, verification, and validation activities
Support regulatory and internal audits
Robust knowledge of FDA regulations, cGMP, and data integrity
Analytical troubleshooting and problem-solving skills
Documentation and compliance expertise
Team collaboration and communication
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
📌 Analyst, Quality Control Chennai
🏢 Endo Pharmaceuticals
📍 Chennai