* Support establishment, implementation, maintenance, and continuous improvement of the QMS aligned with ISO 13485 requirements.
* Ensure compliance with regulatory, customer, and internal quality requirements.
* Support Complaint Management, CAPA, deviation, change management, and risk management activities.
Document Control & Record Management* Manage the complete document lifecycle including creation, review, approval, revision, archival, and obsolescence.
* Ensure compliance with Good Documentation Practices (GDP) and ALCOA+ principles.
* Maintain PLM, document master lists, and audit-ready records.
Project Management - Quality Initiatives* Lead and support Quality and QMS related projects.
* Develop project plans, timelines, milestones, and track progress to ensure ontime delivery.
* Coordinate with cross-functional teams and proactively manage risks.
Warehouse (WH) Quality Management* Provide quality oversight for warehouse operations including storage, handling, and dispatch.
* Support warehouse qualification, audits, and quality agreements.
* Ensure WH processes comply with SOPs and regulatory requirements.
Internal Audit & Management Review* Support planning, execution, and follow-up of Internal Audits in line with ISO 13485.
* Support Management Review activities including KPI data collection, presentations, and action tracking.
Training & Stakeholder Management* Support QMS, GDP, and quality system training activities.
Qualifications & Certifications* Bachelor's/master's degree in science, Pharmacy, or a related discipline.
* Preferred ISO 13485 Certified Professional.
* Preferred Lean Six Sigma Certified.
Professional Experience & Skills* 8-9 years of experience in Quality Assurance / Quality Systems within regulated industries.
* Strong experience in Document Control, Warehouse Quality, and Commercial Quality activities.
* Excellent communication, audit, and project management skills.
