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Analyst, Global Stability at Endo

Tiruporur, tamil nadu, India -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

0.0

Posted On

27 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Regulations, cGMP, Data Integrity, Analytical Troubleshooting, Problem-solving, Documentation, Compliance, Team Collaboration, Communication

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Experienced Analytical/Quality Control Analyst with 3–5 years of hands-on experience in an FDA-regulated pharmaceutical environment. 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. Strong 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 Key Skills: Strong knowledge of FDA regulations, cGMP, and data integrity Analytical troubleshooting and problem-solving skills Documentation and compliance expertise Team collaboration and communication Come join us! At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Responsibilities

Perform routine and stability sample analysis using instruments like HPLC and GC while ensuring compliance with cGMP and data integrity principles. Investigate OOS/OOT results and support regulatory audits, deviations, and CAPA activities.