Sajid Barwelkar
Navi Mumbai
Summary
Accomplished in leading Quality Assurance and Compliance for Cognizant Technology Solution India Pvt. Ltd., I excel in regulatory inspections and GxP audits, showcasing a robust expertise in 21 CFR Part 11 compliance. With a proven track record in enhancing delivery excellence across global centers, my leadership and Black Belt training in process improvement significantly uplift operational standards.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Sr. Manager – Quality Assurance
Cognizant Technology Solution India Pvt. Ltd.
04.2008 - Current
- Currently, leading the audit function for Digital Operations (erstwhile Business Process Services) Business Unit with a team of 8 qualified auditors
- Ensuring Quality and Compliance for India and Global Delivery Centers (North America, Europe, Latin America, China, Japan and Philippines) catering to Business Operations and IT Unit for Healthcare, Banking & Finance, Insurance, Communication & Technology, Retail & Consumer Goods and Manlog
- Ensuring compliance with ISO and respective regulatory & statutory requirements
- Ensuring Risk Management through regular reviews and assessments for the DO Business Unit
- Responsible for SOP Management for the Business Unit
- Responsible for facilitation on Metric management
- Representing QA (Internal Audit) for client interactions and external audits/inspections
- Responsible for overall delivery excellence for the Business Process Services
- Performing UAT for enhancement of internal tools
Sr. Manager – Delivery Excellence (Audit Lead)
Cognizant Technology Solution India Pvt. Ltd.
08.2014 - 07.2019
- Managed audit team consisting of 5 professionals specializing in life sciences.
- Maintained quality and compliance across international delivery centers for business process services and IT.
- Ensured compliance with industry regulations including ISO, GCP/GPV, CSV, 21CFR Part 11 and SDLC processes.
- Performed regular reviews and assessments to manage risks for Life Sciences Digital Operations Business Unit.
- Oversaw development and maintenance of SOP within the Business Unit and Quality domain.
- Facilitated metric management processes.
- Facilitated hosting of client audits and participated in client visits.
- Participated in regulatory inspections as a QA representative.
- Devised action plans for resolution of audit issues.
- Maintained high standards in Business Process Services and IT delivery.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Liaised with auditors to complete annual audits and maintain compliance with local, state and federal requirements.
- Met with business leaders and owners to discuss audits and findings.
- Identified weaknesses of existing control systems and made suggestions for remediation.
- Developed recommendations for improved operational efficiency based on audit findings.
- Used risk-based approach to deliver contract compliance and adherence to service-level agreements (SLA).
- Conducted risk-based audits of operations, processes and systems to ensure adherence to internal policies and external regulations.
- Provided training and mentorship to junior staff members on various aspects of auditing techniques.
- Executed comprehensive audit programs based upon approved audit plan for evaluation of management controls provided over institutional activities.
- Facilitated risk reviews and ensured CSV adherence for internally developed tools during client deliveries.
- Established and sustained System Registry containing validation status information.
- Conducted UAT to improve efficiency of internal utilities.
- Developed long-term relationships with key stakeholders including customers, suppliers, regulatory bodies.
Manager - Quality Assurance (Quality Champion)
Cognizant Technology Solution India Pvt. Ltd.
04.2011 - 08.2014
- Supervised team of Quality Reviewers (Auditors).
- Monitored operational processes to ensure compliance across various global sites.
- Ensured compliance standards for 60+ Life Sciences projects along with numerous counterparts in Banking & Finance sector.
- Executed thorough evaluations of projects for effective risk mitigation.
- Engaged actively in client audits and inspections.
- Maintained adherence to ISO, GCP/GPV, CSV, and 21CFR Part 11 standards.
- Participated in external audits and inspections as the QA liaison.
- Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
- Led team meetings and one-on-one coaching sessions to continuously improve performance.
- Conducted performance evaluations, providing feedback and coaching for team development.
Sr. Associate - Quality Assurance (Quality Reviewer)
Cognizant Technology Solution India Pvt. Ltd.
04.2008 - 04.2011
- Led team of four reviewers, guaranteeing precise and timely QA report submissions for Mumbai center.
- Regularly met targets for audits and reporting SLAs.
- Led initiatives on topics such as Risk Management, CAPA, and Six Sigma.
- Engaged actively in client visits.
- Compiled and updated team performance reports regularly.
- Monitored adherence to ISO standards and processes.
- Analyzed data and created reports for senior management.
- Managed team resources, including assigning tasks, monitoring progress, and ensuring deadlines were met.
- Prioritized and organized tasks to efficiently accomplish service goals.
Asst. Manager, Quality (Quality Lead)
Stream International
01.2007 - 03.2008
- Supervised three Voice and one Web service queues with nine Call Coaches.
- Overseeing the timeliness and correctness of Quality reports.
- Fulfill expected audit and feedback metrics each week.
- Organized and managed weekly sessions focused on resolving goal-related issues.
- Conducted monthly reviews for all queues.
- Conducted and reviewed fortnightly product tests across all queues.
- Participating in all the client calls
- Preparing and maintaining team’s performance incentives and absenteeism report
- Driving Quality metrics across the multiple service queues and adhering to the Quality norms
- Ensuring compliance with ISO processes
Sr. Quality Coach and Process Trainer
Stream International
06.2006 - 12.2006
- Heading a team of 4 Quality Coaches
- Evaluating calls on a daily basis and providing feedback to the agents and team managers
- Attending all the client conference /calibration calls
- Discussing various issues and updates with the team and conducting training sessions for the agents
Sr. Quality Executive (Quality Control Lead)
Transworks Information Services Pvt. Ltd.
05.2005 - 05.2006
- Company Overview: An Aditya Birla Enterprise
- Leading a team of Quality Executives and supervising agents
- Adhering to client defined quality norms
- Monitoring transactions for the team
- Preparing and maintaining reports for quality, productivity and service levels of the team
- Providing regular & systematic feedback to team on performance indicators
- Handling Client Complaints and communicating product updates to the team
- Identifying process level issues and working out corrective measures for the concerned areas
- Ensuring compliance with COPC & ISO processes
- An Aditya Birla Enterprise
Quality In-Charge
Transworks Information Services Pvt. Ltd.
05.2005 - 05.2006
- Company Overview: An Aditya Birla Enterprise
- Improving quality level in order to meet client’s expectations
- Training on Insurance and various processes involved for the same
- Bringing about changes to the Quality process and work towards achieving 100% accuracy
- An Aditya Birla Enterprise
Sr. Associate-Web
Transworks Information Services Pvt. Ltd.
08.2002 - 04.2005
- Company Overview: An Aditya Birla Enterprise
- Led CSR team in troubleshooting and resolving complex technical problems.
- Generated and maintained routine performance reports.
- Assessing relevant skills and product understanding among team members.
- Maintained compliance with COPC standards and documented all processes.
- Upheld company policies and ethical guidelines consistently.
- Diagnosed and fixed various problems within the client’s lab environment.
Supervisor and Quality Executive
02.2002 - 07.2002
- Planning optimum staffing during the shifts
- Adhering to client defined quality norms
- Monitoring transactions for the team
- Preparing and maintaining quality scores, productivity and service levels of the team
- Providing regular & systematic feedback to team on performance indicators
- Communicating product updates to the Team
- Rendering support to team members to resolve difficult queries and providing coaching in improvement areas identified for team members
- Handling & recording escalations appropriately
- Preparing & maintaining daily reports
- Verifying necessary skills & product knowledge for team
- Ensuring compliance with COPC processes & documentation
- Adhering to guidelines for code of conduct for self and team
Quality Control Executive
03.2001 - 01.2002
- Monitoring performance of all the CSRs as described in the Quality Guide
- Providing regular feedback to CSRs and Team Leaders
- Analyzing dissatisfaction reports received from clients and giving feedback to CSRs
- Identifying challenge areas and suggesting methods to improve quality, both at individual level and at program level
- Identifying bottom quartile CSRs, facilitating retraining with Team Leaders/Trainers and closely monitoring their post training performance
- Maintaining reports on CSRs performance on a daily, weekly and monthly basis
- Complete and update MIS, finalize quality reports every end of the month and submit reports to designated persons
- Participating in Client Monitoring sessions and sharing client feedback with Team Leaders / Trainers / Agents
Customer Support Representative (CSR)
12.2000 - 02.2001
- Handling customer queries and troubleshooting their email problems
- Escalating out-of-support boundary mails to the client
- Meeting daily targets and completing reports
- Sharing quality related updates with the entire team and getting into discussion, if required
- Attending the product training conducted by the client on a regular basis
Education
Bachelor of Science - Chemistry With Drugs And Dyes As Applied Component
MUMBAI UNIVERSITY
05-1999
Post-Graduate Diploma in Business Administration (PGDBA) - Operations Management (Incl. Total Quality Management)
Narsee Monjee Institute for Management Studies (NMIMS)
Skills
- GxP and Risk-Based Audits
- Regulatory Inspections
- Expertise in 21 CFR Part 11 Compliance (Computer System Assessments)
- Data Privacy Lead Assessor
- Black Belt trained (Green Belt certified)
- Quality Management
- ISO 9001:2015
- ISO 27001
- ISO 13485:2016
- ITIL
- ESCM-SP2
- COPC
- Microsoft Office
Certification
- ISO 9001:2015, Maintaining organization Quality Management Systems according to ISO 9001:2015 requirements.
- ISO 27001:2013, Ensuring project teams are adhering to the requirements of an Information Security Management System.
- ISO 13485:2016, Gap analysis, process engineering and facilitations to Medical Devices engagements.
- DCPLA, Data Privacy program for India.
- PGDBA, Post-Graduate Diploma in Business Administration from NMIMS.
Trainingprograms
- Post-Graduate Diploma in Operations Management
- Data Security Council of India (DSCI) certified Privacy Lead Assessor
- Computer System Validation & 21CFRPart11 from FDA Smart
- ICH-GCP from University of London
- Certification for Software Quality Assurance (CSQA)
- Leadership Style as a Coach - Situational Leadership
- Six Sigma (Black Belt) training at KPMG, Chennai
- Six Sigma (Green Belt) Certificate
- PMI Project Management Professional (PMP) – Self-Paced Learning
- Team Building and Management Skills
- COPC Planning and Implementation
- ISO Standards and Implementation
- Personality Development & Public Speaking
- Partnering with your Manager
- Professional Skills for Voice
- Leadership Development Program
- Business Continuity Management
- Advance Excel from Udemy
Languages
- English
- Hindi
- Urdu
- Marathi
- Arabic
Awards
- Passed “Grade A” Examination for National Cadet Corps (N.C.C.) during Secondary School
- Won several awards @ Cognizant between 2008 and 2023 for exceptional performance.
Professionalprofile
Highly professional Life Sciences & Healthcare Regulatory, Quality Assurance & Advisory profile seeking to obtain a leadership position with a solid, growth-oriented company. Wishing to leverage my skills and experience in the GCP, GPV, HIPAA Compliance, Risk Management, Process Excellence, and IT enabled Service areas., Science graduate by education with over 24 years of experience in the Quality Assurance and Life Sciences Regulatory areas for IT & ITES organizations. Proven track record of delivery and process excellence.
Personal Information
- Passport Number: X5212986
- Number of Children: 2
- Date of Birth: 08/19/78
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Affiliations
- Passed Grade A Certification of National Cadet Corps
- Won 1st Prize in the 'Vision 2020' event for best Quality and Compliance model
- Won multiple awards in Quality Assurance department
References
References available upon request.
Timeline
Sr. Manager – Delivery Excellence (Audit Lead)
Cognizant Technology Solution India Pvt. Ltd.
08.2014 - 07.2019
Manager - Quality Assurance (Quality Champion)
Cognizant Technology Solution India Pvt. Ltd.
04.2011 - 08.2014
Sr. Manager – Quality Assurance
Cognizant Technology Solution India Pvt. Ltd.
04.2008 - Current
Sr. Associate - Quality Assurance (Quality Reviewer)
Cognizant Technology Solution India Pvt. Ltd.
04.2008 - 04.2011
Asst. Manager, Quality (Quality Lead)
Stream International
01.2007 - 03.2008
Sr. Quality Coach and Process Trainer
Stream International
06.2006 - 12.2006
Sr. Quality Executive (Quality Control Lead)
Transworks Information Services Pvt. Ltd.
05.2005 - 05.2006
Quality In-Charge
Transworks Information Services Pvt. Ltd.
05.2005 - 05.2006
Sr. Associate-Web
Transworks Information Services Pvt. Ltd.
08.2002 - 04.2005
Supervisor and Quality Executive
02.2002 - 07.2002
Quality Control Executive
03.2001 - 01.2002
Customer Support Representative (CSR)
12.2000 - 02.2001
- ISO 9001:2015, Maintaining organization Quality Management Systems according to ISO 9001:2015 requirements.
- ISO 27001:2013, Ensuring project teams are adhering to the requirements of an Information Security Management System.
- ISO 13485:2016, Gap analysis, process engineering and facilitations to Medical Devices engagements.
- DCPLA, Data Privacy program for India.
- PGDBA, Post-Graduate Diploma in Business Administration from NMIMS.
Bachelor of Science - Chemistry With Drugs And Dyes As Applied Component
MUMBAI UNIVERSITY
Post-Graduate Diploma in Business Administration (PGDBA) - Operations Management (Incl. Total Quality Management)
Narsee Monjee Institute for Management Studies (NMIMS)
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