Tech Qualitas is a provider of cost-effective compliance services in the area of regulatory compliance, Computer System Validation and QA Services to Pharmaceuticals, CROs, Biotech’s, Medical Device Companies, Academic Institutions and Government Institutions. Our Quality Management Solution provides end-to-end management of QA services with different customized integrated and individual modules available as per customer business processes in line with compliance:• Document and Content Management Solution• Change Control Management• User Access Management• Training and Learning Management Solution• Deviation and CAPA Management

• Establishing overall quality management w.r.t Computer System Validation of projects impacting regulatory (GxP i.e. GMP, GCP, GLP etc.).• Establishing & implementing Computer System Validation and IT Policies, SOPs, and Guidelines at organization level.• Ensuring regular training's of processes for effective operational use. • Supporting continuous improvement within the validation department.• Ensuring regular compliance internal audits. Provide guidance & support and ensure closure of audit findings with the help of desired team.• Providing desired support related to computer system validations during audits & inspection done by regulatory agencies.• Establishing documentation group under CSV to control and maintain APCER controlled documents globally.• Establishing Computer System Validation practices as CSV Services to APCER customers in the long run. • Meeting and contacting APCER’s clients or potential clients and vendors, and communicating the value proposition to clients or potential clients about APCER IT solutions and the CSV services of APCER Life Sciences globally.

• As validation/QA lead, responsible to determine the extent of validation needed for a particular system/project and authoring and reviewing various validation deliverables such as Validation Master Plan, Requirements Specification, System Architecture Plan, Test and/or Qualification Plan, IQ, OQ, PQ, Traceability Matrix, summary reports, VSR etc.• Educating team for projects execution, change management, quality standards, and Good Documentation Practices (GDP).• Developed and Implemented Global Policies / SOP’s / Guidelines related to QA, Validation, SDLC, and Operational processes from scratch across all locations of DBMS and trained all employees and consultants on these processes.• Performed internal audits periodically across all locations of DBMS to ensure compliance with DBMS processes and regulatory requirements along with providing corrective action recommendations in the event of inconsistencies.• Ensuring CAPA activities are closed and collect evidence of same.• During global role, participated in pharmaceutical industry audits of validated computer systems, and supporting clients in such pharmaceutical industry audits.• Managed client relationship and status communications, providing oversight of the project execution of various tasks to customer through various Project Review meetings with customer. As project lead, I was Responsible for providing guidance and task execution information to project teams.• As project lead, responsible for aligning resources to different projects based on skills of team members and timeline for project completion. Team members were functional and technical resources in addition to testers. • As project lead of Software development team, I was responsible to ensure product is developed as per customer requirements, Execution of Unit/Integration testing before demo of minor release of product with business users.

• Participating in the development/Implementation Global Policies / SOP’s / Guidelines across all locations• Developing validation plans for specific computer system implementation project• Assisting in development, implementation, and enforcement of computer validation policies and practices Protocol, execution work, and final report review and approval• Participation in the change control program for modifications to qualified systems• Understanding existing systems functions and liaison with project teams to execute validation activities. • Coordinating between internal departments, including Information Technology, Quality Control, Quality Assurance to manage and track validation requirements status throughout the project • Conducting training sessions for users on SOP’s & Computer System Validation Concepts• Handled IT, e-submissions, SAP upgrade, Solution Manager, GLP projects at Ranbaxy.

• Participating in the development/Implementation Global Policies / SOP’s / Guidelines across all locations• Developing validation plans for specific computer system implementation project• Assisting in development, implementation, and enforcement of computer validation policies and practices Protocol, execution work, and final report review and approval• Participation in the change control program for modifications to qualified systems• Understanding existing systems functions and liaison with project teams to execute validation activities. • Coordinating between internal departments, including Information Technology, Quality Control, Quality Assurance to manage and track validation requirements status throughout the project • Conducting training sessions for users on SOP’s & Computer System Validation Concepts• Handled IT, e-submissions, SAP upgrade, Solution Manager, GLP projects at Ranbaxy.