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Manager, Software Quality Assurance

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Manages validation strategy and approach to ensure a scalable approach to computerized systems validation. Manages software validation strategies to ensure quality of software developed and release and ensure its conformance with regulatory requirements related to validation of computerized systems Manages validation team members throughout the products/project software development life cycle. Acts as a Software Validation Lead on software validation efforts. Assists in creation/maintenance of Standard Operating Procedures and validation documentation templates. Manages and mentors Software Validation Engineers. Provides guidance and direction for validation department strategies and project level validation efforts. Manages development and maintenance of test cases, scenarios and test data including traceability to requirements for projects under validation and verification. Supports client and regulatory agencies audits as required. Reviews and approves validation documentation. Skills Excellent knowledge of software validation and verification techniques and test case development. Experience in management/project leadership of software validation engineers. Experience managing multiple concurrent projects. Experience with test case design and strategy. Experience with development of standard operation procedures and validation documentation templates. Knowledge of software development languages and tools such as C# and SQL. Knowledge of relational databases, preferably SQL Server. Familiarity with database design and/or testing. Knowledge of clinical data management process for FDA regulated companies is a plus. Familiarity with FDA regulations such as 21 CFR Part 11 and GxP desirable.Extensive knowledge/exposure in Automation and Performance Testing using tools like QTP, Selenium
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 12-17


Project Leader/ Project Manager | Quality Assurance/Testing
Applying for this job will take you to an external site


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