Job Requirements:
Minimum 10 years of experience in QA Documentation in the pharmaceutical industry.
Robust knowledge of Revised Schedule M requirements and GMP guidelines.
Experience in preparing, reviewing, and maintaining SOPs, BMRs, BPRs, and other quality documents.
Hands-on experience in Process Validation, Cleaning Validation, and Equipment Validation documentation.
Knowledge of QMS, deviation, CAPA, change control, and audit documentation.
Injectable plant experience is preferred.
Positive documentation, communication, and coordination skills.