Key Responsibilities:
- Manage controlled documents including SOPs, specifications, protocols, reports, and quality records.
- Ensure compliance with GDP, cGMP, Data Integrity, and QMS requirements.
- Handle Document Management System (DMS) activities, document control, version management, and archival.
- Manage Learning Management System (LMS), training assignments, compliance tracking, and training records.
- Coordinate induction, GMP, GDP, SOP, and regulatory training programs.
- Support regulatory inspections, customer audits, CAPA, and Change Control activities.
Key Skills:
- Robust knowledge of GMP, GDP, Data Integrity, and QMS.
- Hands-on experience with DMS and LMS platforms.
- Good communication, coordination, and documentation management skills.
- Proficiency in MS Office applications.
Exposure Required:
- Regulatory environments: MHRA, EU GMP, WHO-GMP, ANVISA.
- Electronic document and training management systems.
- Pharmaceutical documentation and compliance processes.
📌 QA Documentation (Pune)
🏢 Emcure
📍 Pune