Manager - 2 Corporate Quality IT

Location

Mumbai | India

Job description

• 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

Job tags

Salary