Shahnawaz Khan
Quality Assurance
Hyderabad,TG
Summary
Versatile Senior Manager having more than 16 years of experience specializing in quality management system and skilled at planning, implementing and overseeing key improvements in quality system to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
16
16
years of professional experience
2012
2012
years of post-secondary education
2
2
Languages
Work History
Senior Manager
Aurobindo Pharma Ltd.
08.2015 - Current
- Leading 14 member team with below activities
- Product failure investigation (OOS, OOT) with co-ordination with QC and manufacturing team.
- Data Integrity management
- Handling of Process Non Conformance (Deviation).
- Proposing and tracking of CAPA to avoid similar occurrence.
- Handling of product complaint (Market Complaint).
- Co-ordination and preparation of Quality Risk Management (QRM) for any changes or any new implementation at site with data gathering and failure mode and effect analysis tool.
- Performing investigation with investigation tools like Data Gathering, 6M/Fishbone analysis, 5 why analysis, Genchi Genbotsu (Go and see).
- Handling of impact assessment for critical complaint, Non-conformance and Batch failure.
- Coordinating with the manufacturing department for the compliance of cGMP and data integrity.
- Handling of Auditors and compliance.
- Handling of team for all time Audit readiness.
Senior Executive
Dr. Reddy’s Laboratory Limited
04.2014 - 07.2015
- Handling and coordinating the IPQA activities.
- Handling of incident and market complaint investigations.
- Shop floor activity compliance, Audit compliance.
- Review of BPRs.
Senior Technical Assistant
Torrent Pharmaceuticals Ltd.
09.2010 - 03.2014
- Handling of change control, deviation, market complain and tracking of CAPA.
- Handling of OOS & OOT.
- Handling of Process Validation Activities Preparation of protocols, sampling and compilation of reports.
- Preparation and review of SOPs.
- Co-ordination of training activity.
- Preparation and compliance of Training Matrix activity.
- Handling of SAP for recipe updating in BOM.
- Audit compliance.
QA Jr. Assistant
Ankur Drugs & Pharma Ltd.
12.2009 - 08.2010
- In process Quality Assurance activity in manufacturing & packing for Solid dosage form and liquid Injection.
- Independently handling of I.P.Q.A activity.
- Handling of Validation Batches at shop floor, Sampling and Compilation of reports.
- Review of Batch Manufacturing & Packing Records.
Education
Bachelor of Pharmacy -
M.J.P. Rohilkhand University
MBA - undefined
Sikkim Manipal University
01.2011 - 01.2012
M. Pharm - undefined
JNTU
01.2014 - 01.2016
Skills
Strategic planning
Strengths And Achievements
- Having more than 16 Years of experience in Quality Assurance department.
- Strong leadership quality to handle the team, make co-ordination with subordinates and seniors.
- Handling of audits and Audit response preparation & compilation in case of observations.
- Knowledge of SAP, ERP, LIMS, QMS software related to Q.A. functions.
- Trained on performing investigation by US based trainer M/S Meridan and M/S Business Excellence Consulting Inc.
- Trained on Data Integrity by Mr. Peter Baker (Ex-FDA Investigator).
- Trained on Quality by Design (QbD) by Dr. Shivang Chaudhary.
Audits Faced
- USFDA, Dr. Reddy’s Laboratories, 2015-06-01
- USFDA, Aurobindo Pharma Ltd., 2016-01-01
- USFDA, Aurobindo Pharma Ltd., 2017-06-01
- USFDA, Aurobindo Pharma Ltd., 2019-09-01
- USFDA, Aurobindo Pharma Ltd., 2022-05-01
- USFDA, Aurobindo Pharma Ltd., 2023-07-01
- German Regulatory, Aurobindo Pharma Ltd., 2019-03-01
- EU GMP, Aurobindo Pharma Ltd., 2018-05-01
- EU GMP, Aurobindo Pharma Ltd., 2023-01-01
- Health Canada, Aurobindo Pharma Ltd., 2018-01-01
- Health Canada, Aurobindo Pharma Ltd., 2022-01-01
- Russia Health Authority, Aurobindo Pharma Ltd., 2025-02-01
- Suadi FDA, Aurobindo Pharma Ltd., 2019-08-01
- Tanzania-FDA, Aurobindo Pharma Ltd., 2018-01-01
- Uganda audit, Aurobindo Pharma Ltd., 2018-01-01
- Kenya audit, Aurobindo Pharma Ltd., 2018-01-01
- NADFC- Indonesia, Aurobindo Pharma Ltd., 2015-01-01
- ANVIZA- Brazil, Aurobindo Pharma Ltd., 2016-01-01
- ANVIZA- Brazil, Aurobindo Pharma Ltd., 2025-01-01
- MCC- South Africa, Dr. Reddy’s Laboratories, 2015-01-01
- TGA- Australia, Dr. Reddy’s Laboratories, 2014-01-01
Disclaimer
I hereby declare that all statements made above are true & complete to the best of my knowledge & belief.
Timeline
Senior Manager
Aurobindo Pharma Ltd.
08.2015 - Current
Senior Executive
Dr. Reddy’s Laboratory Limited
04.2014 - 07.2015
M. Pharm - undefined
JNTU
01.2014 - 01.2016
MBA - undefined
Sikkim Manipal University
01.2011 - 01.2012
Senior Technical Assistant
Torrent Pharmaceuticals Ltd.
09.2010 - 03.2014
QA Jr. Assistant
Ankur Drugs & Pharma Ltd.
12.2009 - 08.2010
Bachelor of Pharmacy -
M.J.P. Rohilkhand University
Similar Profiles
A UDAYA BHASKERA UDAYA BHASKER
Senior Executive in Production Department at EUGIA PHARMA SPECIALITIES UNIT -III (AUROBINDO PHARMA LIMITED(unit-IV) )Senior Executive in Production Department at EUGIA PHARMA SPECIALITIES UNIT -III (AUROBINDO PHARMA LIMITED(unit-IV) )
RAJASHEKAR ATLARAJASHEKAR ATLA
Sr. Executive, Quality Assurance at Aurobindo Pharma Ltd.Sr. Executive, Quality Assurance at Aurobindo Pharma Ltd.
Sahitya PidaparthiSahitya Pidaparthi
Intern at Aurobindo Pharma ltd.Intern at Aurobindo Pharma ltd.
Gowtham PallekondaGowtham Pallekonda
Software Engineer 3 at WorkspanSoftware Engineer 3 at Workspan
Ganesh JosyulaGanesh Josyula
Senior Technical Consultant at InfovitySenior Technical Consultant at Infovity