Job Summary : The Quality Specialist will be responsible for supporting, maintaining, and improving the Quality Management System (QMS) in compliance with applicable regulatory, quality, and business requirements. The role includes Document Control, complaint Management, Quality Project Management, Commercial Quality Activities, Warehouse (WH) Quality Management, and support to Management Review, Internal Audits, and Continuous Improvement initiatives.Quality Management System (QMS)

* 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 Qualified.

* 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.

experience

10

📌 quality specialist. (Mumbai)
🏢 Randstad
📍 Mumbai