21 Aug
|
Ecliptic Insight Ventures
|
India
21 Aug
Ecliptic Insight Ventures
India
DeepHow | Full-Time | Fully Remote
Job Summary
DeepHow is seeking an experienced Quality Consultant / Lead to independently manage quality assurance, regulatory, and GxP compliance projects for DeepHow and its clients. The consultant will serve as a subject matter expert (SME) in Quality Assurance and GxP compliance while helping establish, maintain, and continuously improve DeepHow’s Quality Management System (QMS). The role will support SDLC, CSV, AI, Data Integrity, and GxP compliance, including the design, implementation, monitoring, maintenance, and continuous improvement of quality programs, policies, and strategies.
Key Responsibilities
● Serve as a subject matter expert in Quality Assurance, regulatory, and GxP compliance.
● Establish, implement, and maintain the company’s QMS program.
● Manage QMS activities including vendor qualification, CAPA management, internal audits, management reviews,
change management, and procedure/SOP review and updates.
● Provide independent consultation and manage quality and compliance projects.
● Support CSV and Data Integrity compliance strategies.
● Support SDLC and risk-based, phase-appropriate GxP projects.
● Monitor regulatory and technological developments affecting GxP compliance.
● Provide GxP consultation to clients and internal functional teams.
● Support investigations involving deviations and non-conformances.
● Provide guidance on appropriate CAPA development and implementation.
● Develop, review, and maintain SOPs and quality procedures.
● Deliver quality and compliance training to clients and internal teams.
● Educate employees at all levels on quality and compliance requirements.
● Promote a culture of continuous improvement and quality across the organization.
● Support other quality, regulatory, and compliance initiatives as assigned.
Required Qualifications
• 10+ years of relevant experience in Quality Assurance, Regulatory, and/or GxP compliance.
• Robust knowledge of applicable US FD
📌 Quality Assurance Compliance Specialist (India)
🏢 Ecliptic Insight Ventures
📍 India