Quality Specialist

BioTechTrek; Pune District; On-site; INR 500,000 - 1,100,000; Full time

Job summary

Ergomed in Pune, Maharashtra, seeks a Quality Specialist to support GxP activities, ensure compliance with ICH, CIOMS, and ISO guidelines, and act as SME for quality operations and training.

You will contribute to quality procedures, policies, and training, while supporting the Ergomed Quality Management System and related processes.

Qualifications

• GxP quality experience required.
• Hands-on with quality systems and document control.

Responsibilities

• Support GxP activities and training requirements.
• Serve as SME for GxP Quality Operations and Training regulations.
• Assist in maintaining and improving QMS and quality processes.
• Provide input to procedures, policies, and training materials.

Skills

GxP Compliance

ICH Guidelines

GCP & GMP awareness

SOP Management

CAPA Management

Audit Support

Deviation Management

ISO Standards

Document Management

Quality Metrics

Job description

# Quality SpecialistErgomed Pune, Maharashtra full-timeFeaturedQuality Specialist### Job DescriptionSupport Ergomed colleagues and functional teams in developing, managing, and implementing controlled procedures.Ensure GxP activities comply with applicable legislation, guidelines, and standards.Support compliance with relevant standards, including ICH, CIOMS, and ISO requirements.Act as a Subject Matter Expert (SME) for GxP Quality Operations and Training regulations when required.Provide input into quality procedures, policies, and training activities.Support the Ergomed Quality Management System and quality processes.### Required SkillsLMS AdministrationLearning Management SystemsQuality Management Systems (QMS)GxP ComplianceGCP and GMP awarenessControlled Document ManagementSOP ManagementGxP TrainingQuality OperationsCAPA ManagementDeviation ManagementAudit SupportInspection ReadinessICH GuidelinesCIOMS GuidelinesISO StandardsBusiness Continuity PlanningQuality Metrics and ReportingSystem Access ManagementCommunication and Collaboration### Job OverviewSalary₹5.0L - ₹11.0LJob Typefull-timeExperience1-3 yearsDeadlineSeptember 15th, 2026Posted1 day ago