Sujaykumar Raut Email & Phone Number

Loughrea, County Galway, Ireland

Dublin, County Dublin, Ireland

• Maintaining Quality Management System compliance with ISO13485, (EU) 2017/745, 2017/746, 21CFR Part 820, and applicable Good Manufacturing Practice regulations within the organization.• Update Quality policies to ensure compliance with quality system needs and relay this information where required.• Manage the inspection of raw materials and components to ensure that they meet specifications and are suitable for use and work effectively on manufacturing quality assurance activities.• Responsible for managing and working on CAPA/NCR, Deviations, Quality Alerts, Supplier Qualification, On-Hold notices, Design assurance activities etc. as applicable.• Responsible for customer complaint handling and maintenance of the customer complaint handling system including the implementation and follow-up of corrective actions.• Support all validation activities within the organization.• Ensure effective investigation and assessment of quality issues e.g. non-conformance and CAPA and productivity initiatives associated with operations• Responsible for Documentation on QT9 and generating reports as required.• Managing project improvement related to the medical device.• Participate in supplier qualification and monitoring for new and existing products including auditing.• Liaise with external parties on the requirement to support quality assurance and regulatory activities.• Provide quality support in the resolution of complaints investigation, CAPAs, and regulatory requirement changes.• Manages a dynamic Risk Management process for all processes within the Let’s Get Checked Organization.

Dublin City, County Dublin, Ireland

Thane, Maharashtra, India

Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports.Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in co-operation with other CPO Departments.Quality Compliance, Reconciliation, Global PV reports, QPPV reports, SOP updates, Deviation and CAPA Management, Non-Compliance investigations, Change Control, Risk Assessment, PV Self-Inspections, Audits and Inspection readiness, Training, Risk Assessment.

Msc. Pharmaceutical Business And Technology, Pharmacy

Master'S Degree, Pharmacology

Bachelors Of Pharmacy, Pharmacy