Manager Validation Development - Hyderabad

Essential Function
The Manager (or Senior Manager) role is a component of RTSM Production. The Manager is responsible for ensuring the provision of validation support for any new or ongoing studies, managing the delivery and validation of tools and applications to support the RTSM function, and managing strategies for client and/or internal projects. The role(s) also manages the creation of consistent validation documentation and the maintenance of a scalable approach to computerized systems validation. The post holder(s) must ensure the provision of 100% customer focus at all times and strict adherence to corporate and where specified, client functional and quality standards.
Relationships
Reports To MGR - Senior Manager/Associate Director/Director, SMGR – Associate Director/Director
Directly Supervises MGR – Associate/Engineer/Senior/Principal, SMGR - Software Validation Engineer Manager
Provides Work Direction to Same as above
Works Closely with Client Services Project Managers, Production staff (all levels), and Quality Management and RTSM Development
External Relationships May be called upon to liaise directly with clients

Qualifications :
Key Accountabilities
Manager:
• Manages software validation daily strategies to ensure quality of software developed and release and ensure its conformance with regulatory requirements related to validation of computerized systems.
• Manages and mentors Software Validation engineers. Provides guidance and direction for validation department strategies.
• Assists in creation/maintenance of test cases, scenarios and test data including traceability to requirements for projects under validation and verification.
• 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.
• Writes, reviews and delivers the formal performance review to their staff.
• Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and/or exceeds both the business and their own personal goals/objectives.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.

Senior Manager (as above, including the following):

• Deputy for Associate Director/Director of Validation Services and/or Validation Development.
• Participate in resource forecasting.
Skills
Manager:
• Excellent knowledge of software validation and verification techniques and test case development.
• Possesses a solid grasp of the management skills necessary for the management/project leadership of software validation engineers.
• Possesses the ability to comfortably manage multiple concurrent projects.
• Extensive knowledge of the development of test case design and strategy.
• Extensive knowledge of the development of standard operation procedures and validation documentation templates.
• Knowledge of software development languages and tools such as C Java, and SQL.
• Knowledge of relational databases, preferably Oracle.
• 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.

Senior Manager (as above, including the following):

• Possesses advanced management skills to enable the leadership, management and motivation of other managers and groups.

Education
• Degree in appropriate discipline or equivalent work experience

Language Skills
• A good knowledge of written and spoken English is required to ensure full communication within project teams and complete understanding of project specifications, test plans and other project documentation.

Minimum Work Experience
• Experience in structured software development life cycle and validation, (preferably including software validation in a regulated industry).
• Experience Managing Validation teams.

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