QA Documentation & Training

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:

• Strong 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.