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.
Positive communication, coordination, and documentation management skills.
Proficiency in MS Office applications.

Exposure Required:
Regulatory settings: MHRA, EU GMP, WHO-GMP, ANVISA.
Electronic document and training management systems.
Pharmaceutical documentation and compliance processes.

📌 Qa Documentation Pune
🏢 Emcure
📍 Pune