Job Responsibilities :
- Prepare and maintain validation documents:
- FAT (Factory Acceptance Test)
- DQ (Design Qualification)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Prepare SOPs, protocols, reports, checklists, manuals, and GMP documents.
- Handle document control, revision, and record maintenance.
- Coordinate with Design, Production, QA, and Automation departments.
- Support FAT/SAT activities and customer audits.
- Ensure compliance with GMP, cGMP, FDA, and GAMP guidelines.
Required Skills
- Knowledge of pharmaceutical machine validation documentation.
- Good understanding of FAT, DQ, IQ, OQ, and GMP documentation.
- Strong MS Office and technical writing skills.
- Good communication and coordination abilities.
Preferred Industry
- Pharmaceutical Machinery / Pharma Equipment Manufacturing