Ravindra Bharambe

Organized and motivated professional with strong time management and organizational skills. Proven ability to adapt and thrive in diverse environments. Committed to contributing to company growth while enhancing personal capabilities.

• Lead Auditor in ISO 13485:2016, SGS Certification Body
• Internal Auditor of ISO 13485, ISO 9001 & ISO 14001, True
• Leadership Growth, True, Tata Management Training Center

• GMP
• WHO GMP
• USAID
• ISO 9001
• ISO 13485
• ISO 14001
• TFDA
• KFDA
• Health Canada
• CE Certification audits

• Date of Birth: 11/12/88
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• English
• Hindi
• Marathi

Responsible to maintain all Quality Metrics data and its representation to the each project manager and take the CAPA if required., Worked on SDLC & familiar with the ISO 62304., Worked in a Agile environment & JIRA., Responsible to monitor the MDR remediation project., Review all deliverables like PMS, Technical documents, DHF, RMF, Packaging summaries etc before the delivery to client., Maintain the review logs for each reviewed files., Maintain the Project Health Index., Raise Customer feedback form and track on it., Maintain the metrics for the respective project., Review of MRM Data., Maintenance & Review of Internal QMS system & training to the project teams., Review of project quality and represent it to customer., Identification and preparation of training plan for the new project., Preparation proposal and project strategy for the new customer., Knowledge in preparation of Master Documents as per ISO 9001:2008, ISO 13485:2016 & ISO 14001:2015., Knowledge in preparation of Documents for CE Certificate., Documentation & all FDA related works., Artwork checking as per country requirement., Assist in preparation of Specification, SOP’s, BMR, MFR, Technical file, Design Dossier, COA, Validation Master Plan and other related documents., Monitoring of Process validation., Conducting OOS & OOT with Quality Analyst., Monitoring the production activities and coordinate with production personnel to fulfill the documentation requirements., Solving queries of customers related to regulatory affair and also handle customer complaints and feedback., Analysis of Finished Drug Substances, Stability Samples by using calibrated instruments., Knowledge of Calibration of instruments like PH meter etc., Good awareness of GLP and GMP through continuous and visual training., Maintaining all proper Documentation record related to Q.C Department., Packing material Inspection & their Bursting Strength testing., Vendor audits as per vendor checklist., Monitoring & verified all microbiology activities.

• Strong interpersonal skills
• Ability to work in teams
• Capability to manage stress
• Sincere, Self confident and positive attitude