- Handling IPQA activities on shop floor and ensuring compliance with GMP practices.
- Preparation, review, and management of QMS documents including SOP, CAPA, Change Control, Deviation, and related documentation.
- Performing Computer System Validation (CSV) activities as per regulatory requirements.
- Coordination with cross-functional departments for quality compliance and documentation.
- Ensuring adherence to regulatory guidelines and audit readiness.
- Exposure to regulatory approved manufacturing plants is mandatory.
Required Skills:
- Valuable knowledge of QA documentation and compliance systems.
- Experience in IPQA, QMS, and CSV activities.
- Understanding of GMP, GDP, and regulatory requirements.
- Good communication and analytical skills.
Preferred Background:
- OSD / API Pharma Plant
- Regulatory Approved Plant Experience Mandatory for IPQA & QMS
- OSD Plant Exposure Preferred for CSV Position