Manager Resume
4.00/5 (Submit Your Rating)
TECHNICAL SKILLS
- CSV
- 21 CFR Part 11
- GAMP
- Testing
- C#.
PROFESSIONAL EXPERIENCE
Confidential
Manager
Responsibilities:
- Computer System Validation, Consultant at Confidential.
- Currently working at client location
Confidential
Validation Manager
Responsibilities:
- Reviewed and approved all validation deliverables.
- Trained the resources on CSV, 21 CFR Part 11 and GAMP5
- Conducted internal Audits and reported the findings.
- Performed effort estimation.
Confidential
Test Engineer
Responsibilities:
- Worked wif BA’s, Development team on product enhancement.
- Involved in Test Plan Preparation.
- Derived High Level scenarios.
- Involved in Effort estimation.
- Performed complete Functional, Integration, Regression Testing and Product testing.
- Performed Installer testing / Compatibility Testing on different OS wif different Service Packs to ensure proper license expiry.
Confidential
Validation Manager
Responsibilities:
- Reviewed and Approved User Requirement Specification and Functional Requirement Specification documents.
- Reviewed and approved design specification documents.
- Coordinated wif Test Lead/team, reviewed and approved IQ, OQ, PQ Plan, Test Plan, and Requirement Traceability Matrix.
- Reviewed and approved Test script for complete coverage - Pre and Post execution.
- Review and Approve Test Summary Report.
- Involved in Effort estimation.
- Conducted trainings on Computer System Validation, 21 CFR part 11.
- Was responsible to ensure dat, all the resources are complied wif LS trainings, Project and Organization Training and keep track of training history of all resources.
- Prepare / Update SOP’s on regular basis and ensured dat each team member is following the guidelines.
- Conduct internal Audits.
- Preparation of Validation Summary Report.
- Conduct all hands weekly meet, track each team status and update the same to management
Confidential
Senior Validation Test Engineer
Responsibilities:
- Worked wif BA’s, Development team in Requirement Analysis.
- Preparation of OQ, PQ Plan.
- Involved in Test Plan preparation and Reporting.
- Prepared High Level scenarios.
- Performed peer review of Test scripts for complete coverage (Pre and Post execution).
- Performed Test execution.
- Analyzing defects and Keep track of status and take them to closure as applicable.
- Enforcing processes for testing as per set standards.
Confidential
Test Engineer
Responsibilities:
- The Unscrambler - A product wif standard in multivariate analysis and design of experiment’s software.
- It is the preferred tool for thousands of data analysts, researchers and engineers around the world who need to analyze large and complex data sets quickly, easily and accurately using the power of multivariate analysis.
Confidential
Test Engineer
Responsibilities:
- Worked wif BA’s, Development team in Requirement Analysis on product enhancement.
- Involved in Test Plan preparation and Reporting.
- Prepared High Level scenarios and Test Scripts.
- Performed Test script review for complete coverage(Pre and Post execution)
- Analyzing defects and Keep track of status and take them to closure as applicable.
- Complete Functional, Integration, Regression Testing and Product testing.
- Installer testing / Compatibility Testing on different OS wif different Service Packs to ensure proper license expiry. (Trial versions, 90 days, 180 days and 360days).
