Naveen Kumar Email & Phone Number

Tijara, Rj, In

Bhiwadi, Alwar

 Online submission of licensing (Test License /Manufacturing license/ Import license /License for Retail and wholesale) and Certificates (Free sale / Non conviction/ Market Standing) on CDSCO portal. Work on external and internal meetings & amp; trainings on ISO 9001-2015, ISO 13485-2016, Risk Management- 14971, ICMED 13485 Issue 2, MDR-2017, MRM etc.D&C ACT, AUDIT, COA, VALIDATION, SOP, CHANGE CONTROL, IPQA, CAPA, BMR, SAP, LICENCING, CUSTOMER COMPLAINTS, DEVIATION CGMP, QMS, TRAINING, ARTWORK, CALIBRATION, NC.Analyze operational, customer and compliance data to identify trendsRoot cause analysis for the identified issues, designing CAPAManaging Team's objectives and performancePreparing reports for the management stating trends, patterns, and predictions usingrelevant dataSupporting product life cycle of IVD's with regards to all quality mattersManagement of the Quality Management SystemIVDR Responsible person (subject to appropriate experience and knowledge)Act as the management representative for the ISO 13485 QMS and lead on NotifiedBody and Competent authority engagementSupport in the preparation, maintenance and review of IVD product technical filesSupport in the implementation of the company's regulatory compliance strategy anddevelopment of new productsData AnalysisKey player in driving continuous improvement of the QMSDevelop and implement quality controls and departmental standards to ensure qualitystandards, organizational expectations, and regulatory requirementsVendor · Internal Audits · Equipment Qualification · Process Qualification · Qualification Development · Qualification · Validation · Vendor Management · Vendor Audit · Supplier Evaluation · Supplier Risk Management

India

 Assist in internal audit as per schedule with lead auditor. Review of documents SOP’s, STP’s, IHS (In-house specifications). Fill-up if required Document change request, change control, deviation, Incident report Review & prepare: Training Manual, Work flow, Risk Register (RBT), Turtle diagram. Team handling Quality Improvement, Document Control, Audits, CAPA, NC products/OOS, Changecontrol, etc. Inspection and preparation of records as per ISO standards. Inspection and preparation of records as per CE marking. Preparation of SOPs, Formats and other QA/QC related documents and timely revision- Inspection & testing of incoming raw material as per specifications and prepare inspection reports.

New Delhi Area, India

New Delhi Area, India

 Inspection & testing of in-process material as per specifications and prepare inspection reports. Inspection & testing of finished products as per specifications and prepare inspection reports (certificate of analysis). Verification and compilation of BPR. Assist in technical file preparation- Stability. Approval of Artworks before and after printing. To plan all outsourced testing activities (External Calibration, environmental monitoring, water testing etc.) and ensure all reports are received on time. To ensure all control samples and respective records are maintained up to date. Review of logbook (temperature, humidity, dress cleaning, disinfectant preparation and all other records of QC) Analysis of customer complaints related to quality issues and do the root cause analysis. Assistance in validation and calibration of equipment like pH meter, weighing balance, sealing machine, water bath, hot plate, oven, Vernier caliper, scale, etc. Inspection and preparation of records as per ISO standards. Inspection and preparation of records as per CE marking. Training & development of new manpower in the production area w.r.t QC requirements. Preparation of documents and records for various audits - Drug department, ISO, CE & customer audits. Prepare the Documents as like SOPs, BPR, BMR, Finished Good Reports, QC Reports of Raw Materials &Packing Materials & maintenance the Control Sample & Stability. Work on documentation of EXPORT and Product Dossier. CAPA, calibration, validation, risk analysis, product specification, product Realization and other QC activities. Work on ELISA READER and ELISA WASHER, Centrifuge, Autoclave, Bio dot Machine, Laminar Flow, pH meter, Water bath, Spectrophotometer & Incubator.

Faridabad, Haryana, India