Arvind Kumar Koyalkar
Hyderabad
Summary
Manager with more than 15 years of experience in the pharmaceutical and medical device domains. Expertise includes end to end validation of IT applications / systems as per GAMP and Part 11 requirements. Expertise on resource management, stakeholder management, Forecast and time management.
Overview
16
16
years of professional experience
Work History
Manager
Capgemini
Hyderabad
03.2019 - Current
- Ensure an end-to-end process and quality consultation and participation throughout the project lifecycle of the application or system
- Aiding AMS-BAU applications by reviewing change requests for SAP & QMS applications
- Spearheading the execution of projects through impeccable planning and effaceable resource utilization
- Overseeing and tracking the progress of project by monitoring schedules, risks, scopes and resources
- Handling stakeholder expectations and ensuring that projects are delivered within time, budget and scope
- Drafting and submitting compliance reports, validation plans & reports, analyzing traceability matrix, test plans & scripts utilizing various tools
- Preparing test protocols and test summary reports (IQ, OQ, PQ) for GxP projects
- Participation in various internal and external regulatory audits and execution of subsequent compliance
- Managed a team of 20 members working on different projects & BAU activities which includes their onboarding, Project planning, Trainings (if required), and performance reviews
QA Manager
Foresight International
Hyderabad
04.2018 - 10.2018
- Author and review compliance / validation plans
- Review and approve test protocols, scripts, and summary reports (OQ and PQ) on paper
- Generated tasks in JIRA and regularly updated JIRA according to requirements
Deputy Manager
Deloitte
Hyderabad
09.2015 - 04.2018
- Assisted various clients in the compliance of GxP critical systems with the USFDA and 21 CFR Part 11 requirements
- Identify risks & dependencies, Monitor and track schedule, risks, scope, and resources
- Provided consulting support to understand the Observations during Quality Audits & Reviews, and suggested Corrective & Preventive Actions as needed, by following a risk-based approach
- Train and implement all GxP relevant SOP’s across various organizations
- Organize, Facilitate and Conduct training on QMS/Processes SOPs and Guidelines
- Author and review Compliance/Validation Plans & Report
- Review and Approve URS, FRS, DS, Risk Assessment, Trace Matrix, Change Requests, Test Protocols, Test Scripts (IQ, OQ, PQ) in HPALM / Jira
- Participated in Requirement gathering / understanding and support Validation activities
Validation Lead
Freyr Software Services
Hyderabad
04.2013 - 08.2015
- Trained new staff members on validation protocols and best practices.
- Reviewed and validated documents for accuracy and completeness.
- Maintained detailed records of all validations performed, including results of tests conducted.
- Collaborated with internal teams to develop new processes and procedures related to validation activities.
- Generated reports summarizing validation activities for management review.
- Provided high level of training to various roles, thoroughly explaining validation methods and testing procedures.
- Periodic & quality review by sampling the incident tickets, service requests & problem tickets
- Experienced Working at Onsite location & participated in Requirement gathering and validation activities
- Conducted and faced several client and Internal Audits for products and service based projects
QA Analyst
Sameva Software Services
Hyderabad
06.2012 - 03.2013
- Actively participated in preparation and review of CSV artifacts such as VMP, VSR, RTM and Test artifacts and execution of Test scripts IQ, OQ, and PQ
- Assisted in developing processes that ensure a high level of accuracy in all aspects of the QA process.
- Maintained policy, procedures, work instructions and projects for quality and continuous improvement agendas.
- Responsible for reviewing the Paper-based testing artifacts, as per GDP and compliance standards
- Experience in requirement analysis, test strategy / planning, comprehensive test Cases development and data analysis
- Identifying Test Scenarios, Test Case Designing, Peer Reviews and executing test cases
- Defect Reporting and Tracking using JIRA
Test Engineer
Azwen Info Technologies
Hyderabad
04.2008 - 06.2012
- hands-on experience in testing of various business applications
- Experience in requirement analysis, test strategy/planning, comprehensive test Cases development and data analysis.
- Identifying Test Scenarios, Test Case Designing, Peer Reviews and executing test cases
- Defect Reporting and Tracking using HP-ALM
Education
Bachelor of Technology - Electronics And Communications Engineering
Nizam Institute of Engineering And Technology
Hyderabad06.2007
Skills
- Computer System Validation
- 21 CFR Part 11
- Project Management
- Compliance & Risk Assessment
- Change Management
- Team Management
- Team Appraisals
- Trainings
- Performance Management
- Team Leadership
- Time Management
Timeline
Manager
Capgemini
03.2019 - Current
QA Manager
Foresight International
04.2018 - 10.2018
Deputy Manager
Deloitte
09.2015 - 04.2018
Validation Lead
Freyr Software Services
04.2013 - 08.2015
QA Analyst
Sameva Software Services
06.2012 - 03.2013
Test Engineer
Azwen Info Technologies
04.2008 - 06.2012
Bachelor of Technology - Electronics And Communications Engineering
Nizam Institute of Engineering And Technology
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