PROFESSIONAL HIGHLIGHTS:

• 11+ years of progressive experience in Quality Assurance and Compliance, System and Software Validation, Risk Management, Change Management, Audits and CAPAs management
• Proficient in providing Quality and Compliance guidance and performing Risk Assessments for IT Solutions, Computer Systems and applications
• Over four years of Validation and Quality Assurance experience in regulated Pharmaceutical industry environment
• Strong 7+ years of manual and automation testing and test management experience in system, performance, functional, integration, smoke, stability, regression and alarm testing.
• Well - versed in authoring and reviewing User Requirements, Functional Requirements, Design Specifications, Test Plans, Test Execution Runs, Defects, Change Management requests, per 21 CFR Part 11.
• Well-experienced in authoring and reviewing GxP SDLC documents, Work Instructions, Protocols, SOPs, Validation Project Implementation Plans, Data Migration Plans, Validation Protocols - IQ, OQ and PQ, UAT Test Summary Reports, Validation Summary reports and traceability matrix.
• Experienced in performing stage-gate assessments.
• Experienced in Requirement Analysis; test scope, test plan and test schedule development; high-level/ low-level test scenario development; development of test cases, test scripts and test data sets; test environment and manual and automated test execution.
• Experienced in Supplier management and 3rd party vendor management
• Extensive experience in reporting, Quality metrics and dashboards generation.
• Proven ability to identify gaps, potential areas for process improvement and communicate these to line management or appropriate internal stakeholders.
• Excellent interpersonal, communication and follow up skills with extensive experience of leading cross-functional global teams.
• Good hands-on knowledge of Software Development Life Cycle (SDLC), Agile Methodolgy and Software Testing Life Cycle (STLC).
• Extensive experience in managing teams and handling work allocations, resourisng, appraisals, projecting planning, budget allocations.
• Working knowledge of SAP ERP applications

TECHNICAL SKILLS:

Operating Systems: Linux, Windows 10, Windows 8, Windows 7, Windows XP, Mac OS

Software Tools: HP ALM, HP Quality Center, HP Service Center, HP Service Manager, SAP CRM, PDOCs, SharePoint, WebEx, RICEF, Citrix, VSS, LMS, MS Visio, MS Office, Ethereal, IxNetwork, IxLoad, IxExplorer, Documentum

Computer Systems: Alcatel 7750, SAM 5620, Cisco CSR, Cisco 6509E, Cisco 3750, Ixia XM12/ X16, Adva FSP150 CPMR, Adva FSP150 CCF-825, Adva FSP150 CM, Adva FSP NM, Juniper T640

Programming Languages: C, DQL, TCL/ TK

WORK EXPERIENCE:

Confidential

Quality Assurance and Compliance Lead

Responsibilities:

• Review and approval of User Requirements, Functional Requirements, Technical Requirements, Test Scripts, Batch records, Test Execution Runs, Defects and Change Management requests per 21 CFR Part 11
• Authoring and review of Validation Protocols - IQ, OQ and PQ, Validation Project Implementation Plans, Data Migration plans and Decleration of Validation documents
• Authoring and review of GxP SDLC documents, slide decks, technical reports, work instructions, protocols, SOPs, test summary reports and traceability matrix
• Providing QA and validation support to individual SAP projects on Quality Control, Compliance issues, Risk Assessment and stage-gate assessments
• Periodic data extraction for reporting and publishing to verify achievement of project Service Level Agreements baselines
• Performing internal audits, preparing responses to deviations reported in external audits and CAPA management.
• Obsoleting Technical Requirements, Functional Requirements and Test Scripts
• Responsible for work allocation, resoursing, appraisal review, projection planning and budget allocations for the team.
• Assisting in supplier management for critical projects

Confidential

QA Test Lead

Responsibilities:

• Coordinating requirement analysis, development, testing and delivery of Change Requests (CRs)
• Production of Acceptance/ Validation Testing and deployment sign-off reports
• Defect detection, reporting and resolution of Go-Live and Migration issues
• Performing internal audits and preparing responses to deviations/ findings reported in external audits.

Confidential

Technical and Validation Lead

Responsibilities:

• Planning, scheduling and managing end to end testing for Operational Readiness, UAT and Real-time Customer Trials in BT Live Networks
• Requirement Analysis; development of test scope, test plan, test scenarios, test cases and test data sets; test environment readiness and application access readiness
• Defect Detection and Resolution
• Review and approval of validation deliverables as per defined SOPs
• Authoring and approval of end summary and exit reports
• Performing internal audits

Confidential

Test Lead

Responsibilities:

• Development of test plans, test schedules, testing scope, test cases and test scripts for fully and automated testing of Layer 2 and Layer 3 network devices
• Perform end to end device configurations, functional and performance based testing, alarm testing, defect management

Confidential

Test Analyst

Responsibilities:

• Command Line Interface (CLI) and Web-based interface development and testing
• Testing and maintenance of existent FASTPATH® functionality