Bengaluru
We are looking for an experienced QMS Consultant to establish and implement a robust Quality
Management System (QMS) across the organization. The consultant will be responsible for
creating quality processes, SOPs, compliance frameworks, training systems, audit readiness
programs, and documentation controls to support upcoming pharmaceutical partnerships and
regulatory requirements.
Experience Required
● 3–5 years of experience in Quality Management Systems (QMS), Quality Assurance,
Compliance, Pharmacovigilance, Healthcare, Clinical Research, or Pharmaceutical industries.
● Proven experience in implementing QMS from scratch.
● Experience supporting pharmaceutical client audits and compliance programs.
● Strong knowledge of SOP management, CAPA, document control, training management, and internal audits.
Key Responsibilities
● Design and implement the organization's QMS framework.
● Develop and maintain SOPs, policies, forms, templates, and quality records.
● Establish document control and version management processes.
● Implement CAPA, deviation, risk management, and change control systems.
● Create training matrices and ensure employee compliance training.
● Conduct internal audits and drive audit readiness activities.
● Develop quality dashboards and compliance reporting mechanisms.
● Support leadership in preparing for pharmaceutical partner audits and assessments.
Key Deliverables
● Fully implemented QMS framework.
● Quality Manual and SOP ecosystem.
● Training and compliance tracking system.
● CAPA and risk management processes.
● Internal audit program and audit readiness assessment.
● Complete documentation required for pharmaceutical partner onboarding.