QA Documentation & Training

Emcure; Pune District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Emcure is seeking a compliance and documentation specialist to manage controlled documents, SOPs and quality records in a GMP environment. You will ensure GDP, cGMP, data integrity and QMS compliance, handle DMS/LMS activities, and coordinate training programs across departments.

The role supports regulatory inspections, audits and CAPA, requiring strong communication and documentation skills within an Indian pharmaceutical setting.

Qualifications

• Experience with regulatory frameworks and quality systems.
• Proficiency in document and training management processes.
• Ability to coordinate cross-functional training and audits.

Responsibilities

• Manage controlled documents, SOPs, specs, reports and quality records.
• Ensure GDP, cGMP, data integrity and QMS compliance.
• Handle DMS activities, version control and archiving.
• Oversee LMS, training assignments and compliance tracking.
• Coordinate induction and regulatory training programs.
• Support inspections, audits, CAPA and change control activities.

Skills

GMP

GDP

Data Integrity

QMS

DMS

LMS

MS Office

Documentation

Communication

Coordination

Tools

DMS platforms

LMS platforms

Job description

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.