Job Summary:

Ensure adherence of overall GxP strategic direction for all IT Quality activities and ensure consistent compliance of GxP IT Systems with regulations and corporate quality policies, programs and objectives.

Support building a “Quality Culture” across the organization. Assess compliance and operational issues of the IT quality projects/systems/Company, providing strong leadership, expertise and setting and maintaining IT - Quality standards throughout the Company’s complete value chain.

Job Responsibilities:

· To support the validation of GxP Application Systems including Enterprise Systems, Laboratory system, electronic inventory and user access management system to comply with regulatory guidelines.

· Should have broad knowledge of IT technologies, IT Infrastructure landscape, to be able to understand, give advice to cross functional project team for Infrastructure Qualification of Server, Network, Storage, LAN / WAN, Databases etc. (Physical and Virtual).

· Providing expertise during software development lifecycle to assure that validation of GXP IT systems is planned and executed for user requirements and intended use.

· Manage and support as QA Lead to Validation of IT projects; new system implementation or existing application including plans, protocols/scripts and reports.

· Monitor and approval of the QMS related to Software and hardware for application systems and IT infrastructure in line with the organizational/site specific procedure.

· To support the various phases of Computer System including Planning, Implementation, Maintenance and retirement activities by ensuring compliance with internal / external regulatory requirements

· To Support the IT teams for evaluating the incidents & deviations wherever required and providing guidance and support in closure of the incidents.

· To Support sites to ensure audit readiness with respect to computerized system validation and management.

· To mentor and provide support in the education and training of project team in relevant areas of compliance and validation for GxP IT systems.

Qualification:

Graduate in Computer Science/ Computer Application/ any stream with intensive knowledge of Computer system validation.

5-6 years hands on experience of Computer system validation in life science domain See Less