Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Certification
Languages
Regulatory Domain
Notable Accomplishments
Honors And Awards
Product Therapy Areas
Personal Information
Additional Information
Timeline
Generic

GAURAV SINGH

New Delhi

Summary

Experienced and results-driven Quality/Regulatory professional with an extensive 20-year tenure in GxP-focused organizations within the dynamic realm of the Global Business Environment. Adept at navigating complex regulatory landscapes and driving key strategic initiatives to fruition. Demonstrated proficiency in establishing and optimizing Quality Systems at both Country and Regional levels, ensuring compliance with stringent regulatory requirements while prioritizing Patient Safety and maintaining a steadfast Customer Focus Approach. Proven track record of achieving tangible outcomes and milestones, showcasing an unwavering commitment to excellence in quality management. Skilled in fostering cross-functional collaboration and implementing robust processes to streamline operations and enhance overall quality performance. Committed to driving continuous improvement initiatives and fostering a culture of compliance and excellence across all facets of the organization. Overall expertise lies in seamlessly integrating quality standards with business objectives, thereby bolstering organizational resilience and competitiveness in the global marketplace.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Commercial Quality Operations Head

ABBOTT RAPID DIAGNOSTICS
12.2014 - Current
  • Accountable for being Management representative with Responsibility & Authority for the Quality/Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
  • Responsible for proactively creating Quality Culture related to People, Process, Products & Services to meet customer needs within India, Iran & SAARC Region.
  • Leading Quality initiatives and Improvements Projects.
  • Engages & Provides directions/objectives for compliance initiatives and issues, pertaining to Quality/Regulatory requirements.
  • Ensuring Quality System awareness and compliance to meet Quality Objectives.
  • Managing Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification) and establishing Quality Agreements with approved Suppliers.
  • Managing Distributor Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification) and establishing Quality Agreements with approved distributors to meet Abbott Distributor Excellence Standard. Currently, Managing 60 Distributors, across the region.
  • Ensuring implementation of effective CAPA program across operational site.
  • Collaborate with Abbott global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
  • Facilitating/Performing Quality Audits for Suppliers/Distributors and 3PL (s).
  • Representing Quality Matrix & Key Performance Indicators to Leadership Team (APAC/Global) for INDIA operations.
  • Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.
  • Ensuring quality activities pertaining to Supply Chain of Products meet Abbott Quality/Regulatory standard (Imports, Release, Storage & Distribution under cold chain shipment).
  • Team Management; responsible for planning, assigning, and directing work; appraising performance and guiding professional development; addressing employee related issues and resolving problems.

Regulatory Activities Undertaken

  • IVD Medical Device Registrations and Regulatory Reporting.
  • Review & Approval of Dossiers, documentation, and Regulatory changes for Product registration, submitting regulatory filings to Health Agencies for Product commercialization, and handling (any) follow-up responses or actions required for product licensing.
  • Notifying management of appropriate regulatory changes (e.g., new policies, regulations, guidance’s, compliance dates etc.) and implement any necessary actions.
  • Led Regulatory, labeling & product evaluation strategies aligned to organization & business goals, ensuring timely registration of new products (NPI) for market growth and renewal of product licenses for business continuity.
  • Developed regulatory plans for New Products and Directing registrations of New Product (NPI).
  • Led Product Evaluation/testing/Validation of New/Ongoing products with Ministry Of Health listed National Laboratories for product Licenses.

Senior Manager- Quality & Compliance (Site Head)

HCL TECHNOLOGIES (for Johnson & Johnson)
07.2012 - 12.2014
  • Ensured Implementation of GxP IT Quality requirements in compliance to 21 CFR Part 11, GAMP-5 Standard, J&J Quality System Policies/Procedures, & SDLC requirements for Computerized systems
  • Enforced adherence to J&J Information Asset Protection Policies (IAPP) and compliance Business Partner Risk Assessment Process (BPRA) requirements
  • Reviewing CSV (qualification-IQ/OQ) packages to attain GxP Compliance
  • Ensured Master Service Agreement (MSA) & State of Work (SOW) for J&J Projects are fulfilled and delivered per timeline
  • Performed GxP & Information Security audits; and conducted awareness trainings on IT GxP specific compliances/requirements related to Computer System Validation (CSV).

Manager- Quality Assurance & Control (Country Manger)

LIFE TECHNOLOGIES (INVITROGEN Bio-services India private ltd)
06.2011 - 07.2012
  • Established Quality system for R&D, Manufacturing & Distribution center (for imported products) aligned with ISO 9001:2008 /ISO 13485:2012
  • Ensuring new product transfers from R&D to manufacturing for commercial purpose and respective launches to fulfill Quality norms for New Products
  • Issuance of Quality certificates and authorizing SAP release for Life Tech Products
  • Quality Hold/Release of Imported products from Distribution Center as per Quality Norms.

Deputy Manager- Quality & Compliance

PREMAS BIOTECH (PVT) LTD
07.2008 - 06.2011
  • Established QMS per cGMP/GLP/ICH Q7 requirements to deliver high quality product/services to global customer
  • Performed product and process quality checks to ensure final products that complies to customer requirements
  • Qualified R&D/manufacturing facility to meet GLP/GMP requirements with appropriate validations/qualifications including electronic lab-notebook (ELN) and SDMS (21CFR part 11 compliant) set up.

Senior Scientific Officer- Manufacturing (Vaccines & Sera Division)

PANACEA BIOTECH LTD
04.2004 - 06.2008
  • Validations/Qualifications for Injectable Vaccines facility (Clean room validations per ISO 14644 requirements), Aseptic process validation (Process Simulation through Media filling), Utility System Validation (HVAC & Pharmaceutical Water System (PW & WFI); Preparing User Requisition Specifications (URS), Qualification Protocols (DQ, IQ, OQ, PQ) for new equipment’s; Internal Quality Auditor
  • Maintained Environmental Monitoring programs for clean rooms.

Education

Master of Science - Microbiology

Jiwaji University
Gwalior-Madhya Pradesh
09.2003

Bachelor of Science - Industrial Microbiology

Kurukshetra University, Kurukshetra
Yamuna Nagar-Haryana
07.2001

Skills

  • System & Process Implementations to meet Quality/ Regulatory Requirements
  • Facility Commissioning & Qualification meeting cGMP requirements
  • Regulatory Compliance-Product Registration /License Management
  • Team building/development (Identifying Talent, hiring, mentoring, professional development) to deliver organizational goals
  • People Management (Handled team of 40)
  • Supplier Quality Management & Governance
  • Distributor Quality Management & Governance
  • Validation & Qualifications
  • CAPA Management
  • Quality Risk Assessment
  • Quality Training
  • Change Control Management
  • Quality Audits
  • Quality Metrics Establishment/Monitoring
  • ISO 9001, ISO 13485 compliance, FDA regulations
  • Six Sigma Methodologies
  • Problem-solving skills
  • Team Collaboration & Leadership
  • Decision-Making
  • Supply Chain Quality
  • Quality improvements and System Implementations
  • Regulatory Compliance

Accomplishments

o Led the Abbott Manufacturing operations at Manesar-Gurgaon from year 2014 to Year April2018

o Strategic management of Quality/Regulatory function within healthcare organization.

o Identification, recruitment, and mentorship of talent, fostering professional development for goal achievement.

o Implementation of robust Quality Systems and processes to ensure compliance with regulatory standards.

o Oversight of manufacturing facility commissioning and qualification, adhering to cGMP requirements.

o Governance of supplier and distributor quality management protocols.

o Management of regulatory compliance activities including product registration and license management.

o Effective people management, with experience leading teams of up to 40 members.

o Development and execution of quality assurance strategies to enhance product safety and efficacy.

o Continuous improvement initiatives to streamline processes and optimize resource utilization.

o Collaboration with cross-functional teams to ensure alignment of quality objectives with business goals.

o Risk assessment and mitigation strategies to address potential quality issues.

o Conducting internal audits and assessments to maintain quality standards.

o Development and maintenance of regulatory documentation and submissions.

o Liaison with regulatory agencies to ensure adherence to evolving regulatory requirements.

o Implementation of performance metrics and KPIs to monitor quality performance.

o Development and execution of training programs to enhance quality awareness and compliance.

o Management of corrective and preventive action (CAPA) processes to address quality issues.

o Participation in regulatory inspections and ISO audits, ensuring readiness and compliance.

o Integration of quality management principles into business processes and decision-making.

o Evaluation and selection of quality management software and tools to enhance efficiency and effectiveness.

Certification

  • Certified QMS Lead Auditor for Medical Device QMS (ISO 13485)
  • Certified QMS Lead Auditor (ISO 9001) QMS
  • Certified Six Sigma Professional (Green)

Languages

English
Hindi

Regulatory Domain

  • Drug & Cosmetic Act – 1940, Schedule M1/MIII, ICH Guidelines
  • Medical Devices Rule, 2017
  • ISO 13485, 9001 QMS, 14971
  • US FDA Quality System (21CFR part 210, 211 & 820 Quality System Regulations, MDSAP)
  • GAMP-5, SDLC, ITIL-V3.0
  • WHO Prequalification, cGMP Audits

Notable Accomplishments

  • Led the Abbott Manufacturing operations at Manesar-Gurgaon from year 2014 to Year April2018
  • Strategic management of Quality/Regulatory function within healthcare organization.
  • Identification, recruitment, and mentorship of talent, fostering professional development for goal achievement.
  • Implementation of robust Quality Systems and processes to ensure compliance with regulatory standards.
  • Oversight of manufacturing facility commissioning and qualification, adhering to cGMP requirements.
  • Governance of supplier and distributor quality management protocols.
  • Management of regulatory compliance activities including product registration and license management.
  • Effective people management, with experience leading teams of up to 40 members.
  • Development and execution of quality assurance strategies to enhance product safety and efficacy.
  • Continuous improvement initiatives to streamline processes and optimize resource utilization.
  • Collaboration with cross-functional teams to ensure alignment of quality objectives with business goals.
  • Risk assessment and mitigation strategies to address potential quality issues.
  • Conducting internal audits and assessments to maintain quality standards.
  • Development and maintenance of regulatory documentation and submissions.
  • Liaison with regulatory agencies to ensure adherence to evolving regulatory requirements.
  • Implementation of performance metrics and KPIs to monitor quality performance.
  • Development and execution of training programs to enhance quality awareness and compliance.
  • Management of corrective and preventive action (CAPA) processes to address quality issues.
  • Participation in regulatory inspections and ISO audits, ensuring readiness and compliance.
  • Integration of quality management principles into business processes and decision-making.
  • Evaluation and selection of quality management software and tools to enhance efficiency and effectiveness.

Honors And Awards

  • Achieved “VP Excellence Award” for “Customer Intimacy Connect (A Continual Engagement)” in Year 2023.
  • Achieved Abbott “Customer Centricity Award” for Outstanding Performance and Support to the business (SAARC) in Year 2022.
  • Achieved “Award of Excellence” for the support given to commercial business on “Quality Challenges and NPI’s” - in Year 2022.
  • Recognized and Won 2 “VP Excellence award” in Year 2021 (Project 1. India Legal Metrology Compliance Remediation, & Project 2. Launch of Navica/Panbio Covid-19 Antigen self-test in India).
  • Reviewed/Approved documents for Product registration, submitted regulatory filings to India Regulatory Agency for product licensing and attained Test/Import Licenses for 8 Medical Devices (IVD) including COIVD-19 Detection Products in India, in year 2020.
  • Established Quality framework for Abbott-Rapid Diagnostics Division for India Operations and completed QMS Integration project of Global Abbott Quality & Regulatory.
  • Established enterprise QMS (Agile-PLM) at INDIA Operation site to manage QMS elements (Quality Incidents (QI), CAPA, Audits, SCAR’s, Field Safety Corrective Actions (FSCA), Documentation Management, Change Request (CR) & Change Orders (CO), Complaint Management System (SFDC).
  • Commissioned New Manufacturing Facility for production of Diagnostics (IVD) products. Successfully delivered 15 Product for distribution in year2017 from New/Qualified Facility.

Product Therapy Areas

  • IVD & Medical Devices
  • Recombinant Products (Protein/Enzymes, Monoclonal/ Polyclonal Antibodies, In-vitro diagnostic Reagents)
  • Sterile/Injectable Product, Vaccines (oral/injectable)

Personal Information

  • Date of Birth: 01/05/80
  • Marital Status: Married

Additional Information

• Achieved “VP Excellence Award” for “Customer Intimacy Connect (A Continual Engagement)” in Year 2023.

• Achieved Abbott “Customer Centricity Award” for Outstanding Performance and Support to the business (SAARC) in Year 2022.

• Achieved “Award of Excellence” for the support given to commercial business on “Quality Challenges and NPI’s” - in Year 2022.

• Recognized and Won 2 “VP Excellence award” in Year 2021 (Project 1. India Legal Metrology Compliance Remediation, & Project 2. Launch of Navica/Panbio Covid-19 Antigen self-test in India).

• Reviewed/Approved documents for Product registration, submitted regulatory filings to India Regulatory Agency for product licensing and attained Test/Import Licenses for 8 Medical Devices (IVD) including COIVD-19 Detection Products in India, in year 2020.

• Established Quality framework for Abbott-Rapid Diagnostics Division for India Operations and completed QMS Integration project of Global Abbott Quality & Regulatory.

• Established enterprise QMS (Agile-PLM) at INDIA Operation site to manage QMS elements (Quality Incidents (QI), CAPA, Audits, SCAR’s, Field Safety Corrective Actions (FSCA), Documentation Management, Change Request (CR) & Change Orders (CO), Complaint Management System (SFDC).

• Commissioned New Manufacturing Facility for production of Diagnostics (IVD) products. Successfully delivered 15 Product for distribution in year2017 from New/Qualified Facility.

Timeline

Commercial Quality Operations Head

ABBOTT RAPID DIAGNOSTICS
12.2014 - Current

Senior Manager- Quality & Compliance (Site Head)

HCL TECHNOLOGIES (for Johnson & Johnson)
07.2012 - 12.2014

Manager- Quality Assurance & Control (Country Manger)

LIFE TECHNOLOGIES (INVITROGEN Bio-services India private ltd)
06.2011 - 07.2012

Deputy Manager- Quality & Compliance

PREMAS BIOTECH (PVT) LTD
07.2008 - 06.2011

Senior Scientific Officer- Manufacturing (Vaccines & Sera Division)

PANACEA BIOTECH LTD
04.2004 - 06.2008

Master of Science - Microbiology

Jiwaji University

Bachelor of Science - Industrial Microbiology

Kurukshetra University, Kurukshetra
  • Certified QMS Lead Auditor for Medical Device QMS (ISO 13485)
  • Certified QMS Lead Auditor (ISO 9001) QMS
  • Certified Six Sigma Professional (Green)
GAURAV SINGH