ATUL BORSE
Quality System Lead
Aurangabad
Summary
Results-driven professional with 12+ years of Quality Management System experience in pharmaceuticals and medical devices industries. 8+ years of experience in Handling Quality management system as per ISO-13485 and MDR-2017 (Medical Device Rule). Certified ISO 13485:2016 Lead Auditor
Overview
11
11
years of professional experience
Work History
Lead Quality System
Ethicon, Johnson & Johnson Pvt. Ltd
Aurangabad
05.2014 - Current
- Handling of Market Complaints.
- Responsible for Leading Change control process at site.
- Leading In-process Quality Assurance function
- Leading Record Management process
- Leading management review process
- Handling of department Non-conformances through ETQ-track wise (Site Non-conformance management database)
- Product Release: Review of BMR and Analytical test reports for release of the product for sale
- Qualification & Validation (Instruments and Processes)
- APQR: Preparation and circulation of Annual product quality review
- Data trending with the help of MINITAB
- Leading the backroom channel for supporting external audits (BSI, FDA, Corporate Audits etc.)
- Knowledge preparation of Stability Study trend and Schedules
- Projects Handled:
- Supported in Document revisions due to India MDR Implementation
- Lead QMS Harmonization project: Reviewed all the Quality Related SOPs and aligned with Current manufacturing practices and MDR 2017
- Led Quality Organization restructuring project: Collaboration with cross functional team for revision of Site documents
- Led Cost improvement initiative: Harmonized Raw material, Franchise specifications to reduce Raw material sampling quantities.
Jr. Executive Quality Control
Wockhardt LTD. Biotech Park
Aurangabad
10.2013 - 05.2014
- Executive Quality Control
- Accountabilities:
- Analysis and trending of finished products and stability study samples
- Calibration of HPLC and GC along with all the other vital analytical instruments
- Assist in US-FDA, UK-MHRA, & internal Audits
Quality Control Officer
Ajanta Pharmaceuticals. LTD
Aurangabad
11.2012 - 10.2013
- Analysis of finished products and stability study samples
- Calibration of HPLC and GC along with all the other vital analytical instruments
- Handling of finished goods out of specification and out of trends
- Sampling & analysis of raw materials & finished products
- Assist in US-FDA, UK-MHRA audits along with regular lab audits & Internal Audit Management to ensure quality compliance of the product as per the GLP guidelines
Quality Control Officer
Johnson & Johnson Ltd
Aurangabad
04.2011 - 10.2012
- Analysis of finished products (Sutures and Meshes) and stability study samples
- Sampling & instrumental analysis of raw materials & finished products
- Finished Product/Raw material and packaging material testing report preparations in LIMS
- Release of Finished Product/Raw material and packaging material in SAP
Education
M.sc - Analytical Chemistry
M. J. College
B.sc - Chemistry
Z.B. Patil College
Skills
Knowledge of Medical Device QMS Quality Management System
Handling Quality management system as per ISO-13485 and MDR-2017 (Medical Device Rule)
Market Complaints
ADAPTIV- Change control management systemBatch Release for the sales
Field Actions
Management Review meetings
Annual Product Reviews
Risk management documents
Audit observations, Non-conformances and CAPA’s
Knowledge of Analytical instruments
Experience in facing US-FDA and UK MHRA laboratory and QMS audits
Record Management
Accomplishments
- Certifications:
- Certified ISO 13485:2016 Lead Auditor
Timeline
Lead Quality System
Ethicon, Johnson & Johnson Pvt. Ltd
05.2014 - Current
Jr. Executive Quality Control
Wockhardt LTD. Biotech Park
10.2013 - 05.2014
Quality Control Officer
Ajanta Pharmaceuticals. LTD
11.2012 - 10.2013
Quality Control Officer
Johnson & Johnson Ltd
04.2011 - 10.2012
M.sc - Analytical Chemistry
M. J. College
B.sc - Chemistry
Z.B. Patil College