Job Responsibilities:
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.
Positive 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