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manager qa in Hyderabad

posted:
location
hyderabad, andhra pradesh
function
Information Technology
position type
permanent
reference number
921358
contact
randstad india
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job description

?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.


Benefits
?Its a Product based company .


Client Introduction
?Over the past 32 years, Organisation has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 74 locations throughout 50+ countries around the world, and has over 14000+ employees. We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.

skills

?12 + Years in Software Testing
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

qualification

?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
apply now