CMO QA Analyst

Qualification:- pharm D

Experience 4 Years - 6 years

Key Responsibilities:

1.Lead CMO qualification, requalification, and auditing activities, including audit planning, audit agenda development, identification of observations, and classification of compliance risks.

2.Conduct follow-up on audit findings, evaluate effectiveness of corrective actions, and ensure timely closure of all audit observations.

3.Review and approve CMO Quality Management System (QMS) documents, such as deviations, change controls, OOS/OOT investigations, and CAPA plans, ensuring compliance with GMP and internal QA standards.

4.Provide comprehensive QA support for technology transfers, process validations, analytical method validations, and scale-up activities conducted at CMOs.

5.Strong hands-on experience conducting GMP audits (qualification audits, routine audits, and for-cause audits).

6.Exposure to multiple manufacturing sections, including OSD, Sterile, Creams, and Ointments, with solid understanding

Job Type: Full-time

Pay: Rs60,000.00 - Rs80,000.00 per month

Work Location: In person