We found the following information about Ajit Basrur at Bose Corporation, where Ajit Basrur has worked as a Manager, Quality Systems since 2018. Ajit's total work experience is over 38 years, during which time this expert had at least 11 jobs at different companies to develop professional skills. Ajit studied at the University of Mumbai from 1979 to 1984. This expert received the following certifications: Certified Biomedical Auditor, Lead Auditor Certification, and Problem Solving and Decision Making Program. Ajit Basrur is proficient in four languages: English, Hindi, Marathi, and Konkani. Ajit currently lives in Worcester, Massachusetts. You can contact with Ajit by searching for phone number or email or find additional info by requesting access to this professional's additional details from SoftwareOfficial.
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Ajit Basrur
Last updated May 04, 2024
Contact Information
Workplace
Colleagues
Work History
Manager, Quality Systems
The Mountain Rd, Framingham, MA 01701
Responsible for developing, maintaining and directing an FDA/ISO 13485 compliant quality management system for medical devices. Develop and maintain an efficient and effective Quality Manage...
from Oct 2018
Manager and Principal Consultant
Consulting services in Quality Management Systems for :
Pharmaceuticals (API, Formulations)
Medical Devices
Laboratories (Microbiology, Chemistry and Calibration)
Cosmetics
Jun 2015 — Sep 2018
Director Qa and Ra - Global Compliance
10560 Dr Martin Luther King Jr St north, St Petersburg, FL 33705
Responsible for audits and compliance activities across Healthcare plants in Americas, Europe and Asia. Official Correspondent and US Agent to FDA for Nypro Inc.
Mar 2013 — Jun 2015
Forum Administrator
I moderate the forums on "ISO 13485" and "FDA" sections.. The Elsmar Cove ( www.elsmar.com ) has been on the internet longer than any other quality web site of its kind. and now almost 12 ye...
Nov 2005 — Jun 2015
Erp Core Team Member - Quality, Operations
10560 Dr Martin Luther King Jr St north, St Petersburg, FL 33705
Feb 2012 — Feb 2013
Senior Customer Quality Manager
10560 Dr Martin Luther King Jr St north, St Petersburg, FL 33705
Champion the Customer Quality activities to enhance the customer loyalty.
Feb 2010 — Dec 2010
Senior Director - Audit and Compliance
Lead the Audit & Compliance team across the API and Formulations sites totalling 12 in number.
Mar 2009 — Feb 2010
Manager - Regulatory Affairs and Quality Systems
10560 Dr Martin Luther King Jr St north, St Petersburg, FL 33705
Main responsibility is to ensure Regulatory Affairs and Quality Assurance compliance primarily for the Medical Devices business, but also to extended to Electronics / Telecommunications, Aut...
Dec 2005 — Mar 2009
Senior Microbiologist
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Lead the routine activities of the Microbiology laboratory in API & Biotech facility to provide on-going and compliant support to Operations. The job included Microbiological activities of t...
Oct 2001 — Dec 2005
Assistant Manager - Qa
Developed the QA Department with an effective team of Quality Assurance personnel. Lead to guide and implement the applications and improvements of the Quality Systems as per Regulatory, Int...
Nov 1991 — Oct 2001
Food Microbiologist
Perform Microbiological testing of raw, cooked and canned foods, Perform analysis of water and dairy products like milk, cream etc., Kitchen supervision and monitoring of personnel hygiene
Aug 1984 — Aug 1987
Education
1979 — 1984
1970 — 1979
Occupations
Executive
Manager
Sales Specialist
Supplier
Senior Advisor
Operations Manager
Services Professional
Sales Representative
Advisor
Skills
Quality System
Fda
Validation
Gmp
Quality Assurance
Quality Auditing
Quality Management
Capa
V&V
Iso 13485
Regulatory Affairs
Pharmaceutical Industry
Quality Control
Change Control
Iso
Medical Devices
Root Cause Analysis
Manufacturing
Auditing
Continuous Improvement
Regulatory Requirements
Lean Manufacturing
Technology Transfer
Biotechnology
Six Sigma
Spc
Cross Functional Team Leadership
Aseptic Processing
Process Improvement
Iso 14971
Dmaic
Supplier Quality
Fmea
Cross Functional Team Building
Gxp
Microbiology
Tqm
21 Cfr Part 11
Cleaning Validation
Contract Manufacturing
21 Cfr
Computer System Validation
Iso 14001
Sterilization
Laboratory
Iso Standards
Statistical Process Control
Verification and Validation
Corrective and Preventive Action
Failure Mode and Effects Analysis
Payroll
Hiring
Visual Merchandising
Inventory Management
Recruiting
Customer Service
Time Management
Customer Satisfaction
Sales
Store Operations
Store Management
Management
Merchandising
Retail
Microsoft Excel