Playing Cricket, Learning new things
ARVIND SINGH
Assistant Quality Assurance Manager In Pharmaceutical Industry
Vadodara
Summary
Thorough Quality Assurance Manager creates successful quality assurance strategies and processes. Accomplished at identifying deficiencies and initiating solutions to problems. Experienced performing both process and outbound inspections.
Total 12.1 years of Experience in Formulation, Contraceptive and API facilities. Working in Laboratory Assurance Department (OOS/OOT/DEVIATION/CAPA/OOC/DATA REVIEW/BATCH RELEASE/APPROVAL OF QMS DOCCUMENTS I.E. PROTOCOL, REPORT, SPC, STP, CSV ETC.).
Overview
12
12
years of professional experience
8
8
years of post-secondary education
5
5
Certifications
2
2
Languages
Work History
Assistant Quality Assurance Manager
Alembic Pharmaceutical Ltd
Vadodara, Gujrat
12.2018 - Current
- Performing thorough Quality Management at the Central Validation Lab and Quality control Lab of the company for drug substances and drug products.
- Leading a team of 6 Quality professionals involved in analytical documents review which is generated from analytical method validation, analytical method verification EP/USP, Cleaning method validation, analytical method transfer, Stability, In-Process, RM, PM, Genotoxic impurities such as NDMA, NDEA etc. and outside samples.
- Handling of Laboratory Information Management System (LIMS) activities like review and approval of LIMS master (Test data sheet) of Raw Material, Intermediate and Finished product, LIMS master Migration activity, Error handling in LIMS etc.
- Batch Release: Planning of Raw Material, Intermediate and Finished product release through LIMS and SAP.
- Accountable for reviewing & approving of all QMS documents i.e. Incidents/Deviations, Out of trend (OOT), Out of Specification (OOS), Change Control and Corrective and Preventive action (CAPA) followed by annual trends.
- Accountable for reviewing & approving of the analytical method validation, verification, Method transfer protocol, Report and test data sheet by using DCS and Documentam software.
- Review of periodic Audit trail CDS and non-CDS instrument, Massage Center as Empower, Tiamo, Lab solution, IR Spectra etc.
- Ensuring implementation of Corrective and preventive action for incidents, deviations, Out of Trend (OOT) & Out of Specification (OOS).
- Reviewing and approving all Master documents - Standard Operation Procedure (SOP), Standard Test Procedure (STP), Specification’s document and Master calibration planner, Master preventive maintenance and Computer system validation (CSV) protocols/reports.
- Review and approved the of Analyst and reviewer Qualification protocol/reports.
- Performing Self-Inspection, Internal Audit schedule, agenda and involved in internal Audit/inspection.
- Facilitates regular audit and self-Inspection/Internal audit by coordinating with cross functional team for closure of audit response on time.
- Ensuring the Lab ready to faced audit and provide the data asked by inspector from USFDA, MHRA, WHO, CQA, MCC.
- Responsible for providing Current Good Manufacturing Practice (cGMP), GDP, QMS and Data integrity training program for the team.
- USFDA, WHO, MHRA, EDQM & local FDA Audit, Other Vendor Audits Faced.
Quality Control Executive
Lupin Ltd
Nagpur
06.2015 - 11.2018
- Managed a team of 8 members as a Sectional Head driving the Plants’ production with respect to the Quality parameters and standards.
- Execute the analytical method transfer and analytical method validation activity by planning, preparation of protocol and Report.
- Handling of analytical method validation and analytical method transfer for outside of India like Brazil, Indonesia, Germany and chili for Merck.
- Fully involved during the investigation of incident, OOS & OOT by using QMS software.
- Accountable for reviewing audit trial before approving reports on a daily basis and system audit trial on quarterly basis.
- Established the systems and procedures in accordance to the regularity guidelines for Laboratory Control.
- Reviewed all analytical documents, stability summary reports.
- Issued the Certificate of Analysis (COA) and semi-finished product reports stating whether the product suitable person for expanding the team to shoulder more work.
Quality Control Executive
Actavis Pharmaceutical Ltd (Teva Pharma)
Chennai
08.2014 - 06.2015
- Performed Quality analysis of finished products as an Analyst in Finish Product (FP)section where medicines are deployed post production.
- Analysis of Stability, finished product and Analytical method transfer.
- Support to investigation team for any event in quality preview such as incident, deviation from standardized specification or out of trend.
- Analysis of Dissolution, Assay, Content uniformity (CU), water by KF and related substances (RS) test.
Quality Control Executive
Lupin Ltd
Indore
12.2010 - 08.2014
- Responsible for analysis of Stability and Finish Product section.
- Analysis of different tests like Assay, RS, Dissolution, Water by KF.
- Instrument handled HPLC with Chromeleon software, Karl Fischer with Tiamo software, Electrolab, Sartorius, mettler toledo.
- Supported the team the investigation team of OOS, OOT and Laboratory incident.
Education
Master of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi Proudyogiki Vishwavidyalaya
Bhopal India 08.2008 - 04.2010
Bachelor of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi Proudyogiki Vishwavidyalaya
Bhopal India 07.2005 - 04.2008
Associate of Science - Diploma in Pharmacy
Rajiv Gandhi Proudyogiki Vishwavidyalaya
Bhopal India 07.2003 - 04.2005
Higher Secondary - Science Education
M.P. Board
Bhopal India 07.2001 - 06.2002
High School - Science Education
M.P. Boord
Bhopal India 07.1999 - 06.2000
Skills
Ability to plan, organize and keep going under tight schedule
Certification
Applied Videography
Interests
Additional Information
Marital status : Married
Date Of Birth : 16 May1984
Sex : Male
Marital status : Married
Nationality : Indian
Notice Period : 3 Month
Total Experience : 12.1 Years
Permanent Address: Village Duara, Teonther, Rewa, M.P.
Current Address: Tower 9/202, Labh Residency, Atladra, Vadodara, Gujrat
Personal Statement
I consider my personal strength to include adaptability, flexibility and ability to learn quickly. I have well-developed inter-personal skills with both staff and client while maintaining professional attitude. I can make decisions independently and confident of abilities to succeed as a good and effective person. I am currently seeking a position which will allow me to utilize my skills, knowledge and experience to their full potential.
Date: Yours Sincerely
Place: Vadodara, Gujrat Mr. Arvind Singh
Timeline
Assistant Quality Assurance Manager
Alembic Pharmaceutical Ltd
12.2018 - Current
Driving a Quality Culture
01-2017
Well Done Card for Identifying the method related issues timely
04-2016
Quality Control Executive
Lupin Ltd
06.2015 - 11.2018
Quality Control Executive
Actavis Pharmaceutical Ltd (Teva Pharma)
08.2014 - 06.2015
Loss Control Services for Emergency Response Team training
03-2013
Quality Control Executive
Lupin Ltd
12.2010 - 08.2014
Current Advances in Novel and Parenteral Drug Development
01-2010
Master of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi Proudyogiki Vishwavidyalaya
08.2008 - 04.2010
Applied Videography
12-2006
Bachelor of Pharmacy - Pharmaceutical Sciences
Rajiv Gandhi Proudyogiki Vishwavidyalaya
07.2005 - 04.2008
Associate of Science - Diploma in Pharmacy
Rajiv Gandhi Proudyogiki Vishwavidyalaya
07.2003 - 04.2005
Higher Secondary - Science Education
M.P. Board
07.2001 - 06.2002
High School - Science Education
M.P. Boord
07.1999 - 06.2000
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