Quality/Validation contractor (Backfill)

Responsible for providing technical administrative and implementations support for Software Validation to Enterprise Integration Systems, applications. Ensuring ITIL and FDA part 11, part 820 practices are followed diligently at all times. Always align the IT services provided with the needs of the Business. While the primary focus is on Software Validation systems, architecting, design, installation and setup of the application/s are other core responsibilities for this role.

Principle Accountabilities: Define, design, implement Validated systems in compliance with FDA specifications and Change control

Prepare Standard Operating procedures for the day-to-day maintenance of the applications and underlying systems.

Ensure knowledge pertaining to new implementations and technologies are adequately shared with the team.

Ensure adequate monitoring and controls are in place to ensure stability of the solutions.

Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers and cross functional teams.

Adherence to Service level agreements agreed with the Business. Ensure timely reviews with stakeholders.

Ensure proper retention polices are in place to ensure systems are validated

Propose system enhancements (software and hardware updates) that will improve the performance and reliability of the system.

Make final decisions on administrative or operational matters and ensure operations' effective achievement of objectives.

Review objectives to determine success of operation, involved developing, modifying and executing company policies that affect immediate operations(s) and may also have company-wide effect.

Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.

Required Skills : Quality,Validation
Basic Qualification :
Additional Skills : Validation Engineer