ANAND SAHU
Aurangabad
Summary
Accomplished Quality Engineering Manager with a proven track record at Ethicon, adept in ISO 13485:2016 and Lean Six Sigma methodologies. Excelled in enhancing operational efficiencies and achieving significant quality improvements, while fostering a culture of safety and environmental responsibility. Renowned for strategic leadership and a keen ability to drive cross-functional team excellence.
Overview
19
19
years of professional experience
Work History
Manager Quality Engineering
Ethicon
Aurangabad
09.2014 - Current
- Company Overview: At Ethicon, we are bringing people together from around the world to create innovative solutions that are advancing surgery and having life-changing impacts in health care
- Ethicon Aurangabad; This state-of-the-art suture finishing facility was set up in 1991-1992 and houses the manufacture of sutures and needles
- Many of the sutures are hand-assembled and packaged at the Suture Finishing facility and sterilized after assembly in the in-house facility
- Suture needles are manufactured in-house from stainless steel wire
- The facility has proactively eliminated the use of Chlorofluorocarbons (CFC) since 1995 in the sterilization process to be in line with corporate commitments
- We have a Business Continuity Plan
- This is certified by Johnson & Johnson
- We have won several awards from National Safety Council – India & National Safety Awards from Government of India in recognition of our meritorious performance
- Ensure Quality Assurance operations in compliance with applicable regulations and policies, including FDA, safety and environment
- Coordinate and Lead Internal & external Audits (ISO, WHO & FDA)
- Ensure that Good Manufacturing Practices (G.M.P.) are followed on the shop floor
- Mentor, train and supervise the quality assurance staff
- Improve the efficiency of the Q.A
- Through the use of Process Excellence and Lean principles
- Communicate Quality objectives & metrics across all department and ensure site performance
- Review and approve statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product; including raw materials, in-process and finished products
- Assure personnel are properly trained and developed for their function and future responsibilities
- Review and approve customer complaints
- Ensure customer compliant resolution within timeline and represent the site in CAPA complaint council meetings
- Communicate metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality assurance staff
- Ensure resolution of daily quality Assurance issues, inter- and intra-department
- Provide input to quality assurance reports, requirements and other information in response to requests for proposals, quotes and other business opportunities
- Coordinate with QC department for finished goods test reports
- Conduct reviews of Device History Record and all the associated activities e.g
- Environmental monitoring, calibration etc
- As a part of the release of the batches for sale
- Review of sterilization records for autoclave and EO sterilization
- Provide input to budget planning process
- Utilize cost control initiatives to reduce expenses
- Make recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs
- Engage in the planning and coordinating Quality Assurance program designed to ensure continuous production of products consistent with established standards
- Engage to comply with ISO and FDA requirements
- Responsible for revision / creation of documents like SOP, STP, QAP, SCP, Raw & Packaging material specification required for manufacturing the products
- Accountable for eliminating significant quality issues on shop-floor
- Accountable for effective regulatory agency inspections
- Ensure the correctness and availability of the artwork and CoA to enhance market acceptability
- Ensure compliance to the Quality system requirements
- Utilize Problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision
- To represent Q.A
- Function and provides technical support and information to Production and Sales/Marketing
- At Ethicon, we are bringing people together from around the world to create innovative solutions that are advancing surgery and having life-changing impacts in health care
- Ethicon Aurangabad; This state-of-the-art suture finishing facility was set up in 1991-1992 and houses the manufacture of sutures and needles
- Many of the sutures are hand-assembled and packaged at the Suture Finishing facility and sterilized after assembly in the in-house facility
- Suture needles are manufactured in-house from stainless steel wire
- The facility has proactively eliminated the use of Chlorofluorocarbons (CFC) since 1995 in the sterilization process to be in line with corporate commitments
- We have a Business Continuity Plan
- This is certified by Johnson & Johnson
- We have won several awards from National Safety Council – India & National Safety Awards from Government of India in recognition of our meritorious performance
Assistant Manager QA & EHS
India Medtronic Pvt. Ltd
07.2012 - 09.2014
- Company Overview: India Medtronic Pvt
- Ltd
- Is 100% subsidiary of Medtronic incorporation USA which is the world's fourth largest medical device company and listed in fortune 500 company
- Having products in CRDM, Cardiovascular, Cardiac surgery, Spine, Diabetes and Surgical technologies business
- Currently India Medtronic is having three distribution centers and one technical service centre
- Mumbai warehouse is the main distribution centre where the entire product landed from EOC and further stock transferred done to Delhi & Chennai warehouses
- Handling Post marketing surveillance i.e
- Product holds order, field corrective actions, and complaint reporting independently
- QMS implementation in supply chain & technical service centre and other focused department
- Corporate quality procedure (CQP / Core requirements) implementation
- Conduct distributor internal audit
- Distributor management system, incorporation of Quality, regulatory and EHS clauses in distributor agreement, training, conducting walk through observations and Auditing
- Conducting Internal audit in focused department as per D&C act 1940 & rules 1945, schedule MII, Medical device rules 2017, ISO9001:2015, ISO13485:2016 and applicable WHO TRS
- Reporting audit observations and work closely with auditing department on audit findings as per
- CAPA management
- Initiate CAPA on internal audit findings and DMS
- Quality & EHS Budget planning
- Quality and EHS KPI’s preparation and reporting
- Imparting QMS training to all employees
- Prepare QMS training calendar for all employees and push the prepared training ppt
- In global training site
- EHS compliance in warehouse, technical service centre and all regional sales offices
- Work closely with BARC and other agencies on ionization radiation compliance
- India Medtronic Pvt
- Ltd
- Is 100% subsidiary of Medtronic incorporation USA which is the world's fourth largest medical device company and listed in fortune 500 company
- Having products in CRDM, Cardiovascular, Cardiac surgery, Spine, Diabetes and Surgical technologies business
- Currently India Medtronic is having three distribution centers and one technical service centre
- Mumbai warehouse is the main distribution centre where the entire product landed from EOC and further stock transferred done to Delhi & Chennai warehouses
Sr. Executive Quality
Baxter India Pvt. Ltd.
Gurgaon
04.2008 - 07.2012
- Company Overview: BAXTER INDIA Pvt Ltd is US based MNC & well known in the field of Sterile Manufacturing
- In India Baxter is having three manufacturing facility
- Manesar (Gurgaon), Alathur (Chennai) & (Waluz) Aurangabad
- Manesar Facility manufactures LVP, Intravenous Injections (DNS, NS, RL etc.) and Peritoneal Dialysis Solution
- Manesar is the largest mfg
- Site in India producing Intravenous Solution & Peritoneal Dialysis Solution
- Manesar Facility is W.H.O
- & ISO (13485) Certified manufacturing Site
- Exports Peritoneal Dialysis Solution to South East Asia
- BAXTER INDIA Pvt Ltd is US based MNC & well known in the field of Sterile Manufacturing
- In India Baxter is having three manufacturing facility
- Manesar (Gurgaon), Alathur (Chennai) & (Waluz) Aurangabad
- Manesar Facility manufactures LVP, Intravenous Injections (DNS, NS, RL etc.) and Peritoneal Dialysis Solution
- Manesar is the largest mfg
- Site in India producing Intravenous Solution & Peritoneal Dialysis Solution
- Manesar Facility is W.H.O
- & ISO (13485) Certified manufacturing Site
- Exports Peritoneal Dialysis Solution to South East Asia
Jr. Executive –QA
Promed Export Pvt. Ltd.
06.2006 - 03.2008
- Company Overview: Sentiss Pharmaceutical (Formerly known as Promed Exports Pvt
- Ltd.) is one of the leading India pharmaceutical company which exporters of pharmaceutical formulation to regulated & non-regulated market
- It has been in this field from more than 15 years, certified with ISO 9001:2000
- EU GMP, MHRA & USFDA
- Set up new facility with latest Blow-Fill-Seal (BFS) Technology to comply with USFDA, ANVISA, MHRA guidelines
- Designed as per latest cGMP requirements
- Dedicated to aseptic filling as well as terminal sterilization of small volume parenteral
- Flexibility to produce containers of various shapes & sizes
- Capability to manufacture Solution as well as Suspensions
- Sentiss Pharmaceutical (Formerly known as Promed Exports Pvt
- Ltd.) is one of the leading India pharmaceutical company which exporters of pharmaceutical formulation to regulated & non-regulated market
- It has been in this field from more than 15 years, certified with ISO 9001:2000
- EU GMP, MHRA & USFDA
- Set up new facility with latest Blow-Fill-Seal (BFS) Technology to comply with USFDA, ANVISA, MHRA guidelines
- Designed as per latest cGMP requirements
- Dedicated to aseptic filling as well as terminal sterilization of small volume parenteral
- Flexibility to produce containers of various shapes & sizes
- Capability to manufacture Solution as well as Suspensions
Education
M. PHARMACY - Quality Assurance
Dr. Bhimrao Ambedkar Marathwada University
Aurangabad (Maharashtra) 12-2020
B. PHARMACY - Pharmacy
Shivalik College of Pharmacy
Nangal (Punjab)06-2006
Skills
- ISO 13485:2016 Lead Auditor
- ISO 9001:2015
- Lean Six Sigma Green Belt
- CAPA Lead Investigator
- Supplier & Distributor Audit
- Risk Management
- Environmental Risk Assessment
- Resource Depletion Optimization
- Water Pollution Management
- Air Pollution Management
Disclaimer
I hereby declare that all the information given above is true to the best knowledge and belief. As such I am interesting you sir /madam that give me an opportunity to work under your precious guidance and organization. I assure you that I can discharge my duties to the utmost satisfaction of all superiors.
References
- Mr. Kalpesh Trivedi, CMO Alliance/Quality Manager, Boehringer Ingelheim India Pvt. Ltd, 09833374142
- Mr. Ramesh Babu Manickam, Manager Q.A., Fresenius Kabi India Pvt. Ltd., 08805191976
Personal Information
- Date of Birth: 02/20/81
- Nationality: INDIAN
- Marital Status: MARRIED
Timeline
Manager Quality Engineering
Ethicon
09.2014 - Current
Assistant Manager QA & EHS
India Medtronic Pvt. Ltd
07.2012 - 09.2014
Sr. Executive Quality
Baxter India Pvt. Ltd.
04.2008 - 07.2012
Jr. Executive –QA
Promed Export Pvt. Ltd.
06.2006 - 03.2008
M. PHARMACY - Quality Assurance
Dr. Bhimrao Ambedkar Marathwada University
B. PHARMACY - Pharmacy
Shivalik College of Pharmacy
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