Experience

Intas Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Manager QA

  • May 2016 - Present

  To champion Quality Improvement Program (QIP) for quality system workstream in a Biosimilar Production facility. Responsible for overall coordination of training systems within the company. Manage document control function, master document list, handling and retention of documents To manage creation, issuance, maintenance of Log Books and control stamps to be used in quality assurance department Coordinate and review the Change Control system. Assist in supporting external audits, coordinating activities in backroom and ensuring timely response to documentation requests for auditors. Performs self audits in departments and ensure that the current revisions of documents are available in a timely manner. Maintains quality records and ensure recording of data and reporting of results per applicable SOPs. Investigates and responds to corrective actions related to Document Control, Training and External Standards. Actively monitor the processes involved in the Design Control and Development of devices and to manage and maintain Design History Files. Show less



BioGenex

• United States
• Biotechnology Research
• 100 - 200 Employee

• Manager, QA/RA

  • Jun 2012 - Apr 2016

  Heading Quality Assurance and Regulatory Affairs (Medical Devices) at BioGenex Labs Inc-Fremont Site. Well versed with ISO 13485, 9001 and USFDA QSR, IVDCE, CMDCAS Handled USFDA, ISO, CAFDB, MOH audits of atleast 10 countries. Experienced in Product registrations with the USFDA and regulatory bodies round the globe. Heading Quality Assurance and Regulatory Affairs (Medical Devices) at BioGenex Labs Inc-Fremont Site. Well versed with ISO 13485, 9001 and USFDA QSR, IVDCE, CMDCAS Handled USFDA, ISO, CAFDB, MOH audits of atleast 10 countries. Experienced in Product registrations with the USFDA and regulatory bodies round the globe.



BioGenex

• United States
• Biotechnology Research
• 100 - 200 Employee

• Asst. Manager, Quality Assurance

  • Aug 2010 - Aug 2011

  Handling Quality Assurance and Regulatory Affairs at BioGenex Labs Inc. Well versed with ISO 13485 and USFDA QSR, IVDCE, CMDCAS Handled USFDA, ISO, CAFDB, MOH audits of atleast 10 countries. Experienced in Product registrations with the USFDA and regulatory bodies round the globe. Handling Quality Assurance and Regulatory Affairs at BioGenex Labs Inc. Well versed with ISO 13485 and USFDA QSR, IVDCE, CMDCAS Handled USFDA, ISO, CAFDB, MOH audits of atleast 10 countries. Experienced in Product registrations with the USFDA and regulatory bodies round the globe.



Biological E. Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Asst Manager - Quality Control

  • Dec 2007 - Jul 2010

  Quality Control & Microbiology Sample Management Stability-Vaccines GPT-Microbiology Isolation and ID of Bacteria and Fungi WHO-GMP Quality Control & Microbiology Sample Management Stability-Vaccines GPT-Microbiology Isolation and ID of Bacteria and Fungi WHO-GMP



Vimta Labs

• Hyderabad

• Group Leader

  • Dec 2006 - Dec 2007

  Molecular Biology RT PCR HIV, HBV, TB Quantification Geno-typing Molecular diagnosis GLP Molecular Biology RT PCR HIV, HBV, TB Quantification Geno-typing Molecular diagnosis GLP



Christian Medical College

• Vellore Area, India

• Research officer - Microbiology

  • 2001 - Nov 2006

  Establishment of Reference Laboratories and Networks for Monitoring Anti-Microbial Resistance in India Reference laboratory activities related to S. pneumoniae and H. influenzae such as phenotyping and genotyping Development of Rapid Diagnostic kits for the Identification of Bacillus anthracis Epidemiology and clinical features of Community-acquired pneumonia (CAP) in adult patients in Asian countries Establishment of Reference Laboratories and Networks for Monitoring Anti-Microbial Resistance in India Reference laboratory activities related to S. pneumoniae and H. influenzae such as phenotyping and genotyping Development of Rapid Diagnostic kits for the Identification of Bacillus anthracis Epidemiology and clinical features of Community-acquired pneumonia (CAP) in adult patients in Asian countries