RAQUIB RAUF

Quality Assurance Executive experienced in medical device manufacturing with a focus on ISO 13485 compliance and GMP standards. Managed quality systems and documentation control, driving continuous improvement through effective audits and compliance management. Delivered high product quality and regulatory adherence by coordinating cross-functional teams and implementing robust QMS practices.

• PGDCA, E-Max IT & Industrial Training Board, 90%, 2024
• Kushal Yuva Program, Bihar Skill Development Centre, 93%, 2021

• THEREFORE (QMS Documentation Software)
• TCSiON (ERP)
• Monday.com (Work & data tracking)
• MS Office (Reports, MIS, basic analysis)

• English
• Hindi

• Date of Birth: 07/12/04
• Gender: Male
• Nationality: Indian
• Marital Status: Unmarried

• Supervised daily production activities to ensure targets were achieved as per plan and schedule.
• Managed shop floor operations while ensuring compliance with GMP and company SOPs.
• Handled manpower planning, shift allocation, and team coordination for smooth production flow.
• Monitored in-process activities to maintain product quality and reduce rejection rates.
• Ensured proper line setup, clearance, and readiness before start of production.
• Maintained batch production records (BPR) and ensured accurate real-time documentation.
• Coordinated with Quality Assurance team for in-process inspection and final release.
• Identified production issues and supported root cause analysis (RCA) for deviations.
• Implemented corrective actions to improve productivity and reduce downtime.
• Ensured proper utilization of machines, materials, and workforce.
• Maintained discipline, safety, and 5S practices on the shop floor.
• Coordinated with stores and inventory team for timely availability of raw materials and packaging materials.
• Monitored RM, FG, and minimized production delays.
• Trained operators on SOPs, process requirements, and quality standards.
• Ensured compliance with regulatory and documentation requirements for medical devices.

• Managed and maintained Quality Management System (QMS) documentation in compliance with ISO 13485 and GMP requirements.
• Controlled the complete document lifecycle including creation, review, approval, distribution, and archival of SOPs and records.
• Maintained Master Document List (MDL) and ensured real-time updates for all controlled documents.
• Handled document change control processes including CRN/ECN initiation, tracking, and closure.
• Ensured proper version control, revision tracking, and withdrawal of obsolete documents from all departments.
• Issued and tracked controlled copies of SOPs, formats, and batch records across departments.
• Supported internal and external audits by providing accurate and timely documentation.
• Maintained training records and ensured distribution of updated documents to concerned teams.
• Ensured compliance with Good Documentation Practices (GDP) across all documentation activities.
• Coordinated with QA, Production, and other departments for document updates and approvals.
• Maintained proper record retention and ensured quick retrieval during audits and inspections.
• Supported CAPA, deviation, and NCR documentation with proper tracking and closure.
• Ensured data integrity, accuracy, and completeness of all quality documents.