- 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.
- Good documentation, communication, and coordination skills.