Job Description

Key Responsibilities:

Ensure compliance with GMP, SOPs, and regulatory guidelines. Prepare, review, and maintain QA documentation including SOPs, BMR, BPR, protocols, and reports. Handle deviations, change controls, CAPA, and investigations. Support internal and external audits and ensure timely audit responses. Review batch records and ensure proper batch release documentation. Coordinate with Production, QC, and other departments for quality compliance. Handle Regulatory Affairs activities such as dossier preparation, submission, and follow-ups. Ensure compliance with WHO-GMP, Schedule M, and other applicable regulations. Maintain document control and ensure data integrity.
Requirements:

Experience in QA & RA within a pharmaceutical company is mandatory.

Strong knowledge of GMP, QMS, documentation, and regulatory requirements.

Good understanding of pharma manufacturing processes.

Ability to handle multiple tasks and meet timelines.

Good communication and coordination skills.

Job Type: Full-time

Pay: ₹12,000.00 - ₹15,000.00 per month

Benefits:

Health insurance Leave encashment Life insurance Provident Fund
Work Location: In person