Job Details

• Good verbal and written communication skills required
• Good interpersonal skills; good team player with ability to build relationships.
• Good analytical skills and detail orientation.

• Supporting Pharma Research & Development Applications software implementation at site - 50% KRA.
• Supporting Pharma Manufacturing & Quality Applications software implementation at site - 50% KRA
• Supporting Enterprise and site-specific software new implementations & upgrade of existing applications.
• Key applications to be supported and experience are: Processes & Instruments connected software. Electronic Lab Notebook ( ELN ), Scientific R&D applications, LIMS, Chromoleon, Lab solution, QAMS, Electronic Document Management System ( eDMS ), Central Data acquisition systems (C-DAS), Weighing & Dispense Solution, e-BPR, IPQA, E-logbook, LMS etc.
• Work with Business Process Owners, Site IT and Corporate IT teams to firm up business requirements and develop solution architecture and project plans.
• Work with teams for applications projects implementation and participate in the blueprinting, development and rollout of applications software.
• Handling Applications Level-2 (Medium or High impact) onward issues by providing SME support, applications repeated issue management, system integration challenges, change management & escalation management.
• Ensure standard and harmonized Applications practices & processes are implemented by co-ordination with corporate teams, site IT teams and other manufacturing sites.
• Leverage existing applications, systems and processes.
• Setup application & interface standard, guideline and checklist for various teams.
• Ensure Business and IT user base is effectively trained and positioned to use all available applications functionalities.
• Ensure IT activities are executed according to regulatory compliance standards and IT security norms.
• Work with QA, EHS and IT security teams to ensure compliance requirements are met.
• Complete self-training and monitor training of team members on the relevant SOPs.
• Ensure Job Description, Training Needs Identification and On Job Training for team members involved in GMP activities.
• Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building.
• Participating in periodical SOP reviews and facilitating site teams for various internal/External audits.
• Handle Applications projects rollout plan for site.
• Support Corporate applications initiative plans for site
• Conduct local meetings on Project progress with stakeholders
• Manage vendors / partners / support teams.
• Coordinate & build good working relations with Production, Quality, Engineering, Subject Matter Experts (SMEs) and IT operations team.
• Providing periodic update on projects and issues to site business team, IT management and stakeholders.
• 6 + years of experience in delivering R&D and Manufacturing IT applications and ability to architect solutions, preferably Pharma domain.
• Knowledge of R&D, Manufacturing and Quality processes in Pharma industry. ( R&D, Plant, Engineering, Instruments operations and Labs ).
• Knowledge of interfacing various Instrument Hardware and Software.
• Knowledge of communication protocol and drivers like Serial, Modbus, Ethernet.
• Knowledge of Quality Assurance function and processes would be added advantage.
• Knowledge of Quality Assurance application like : QAMS ( Quality Assurance Management System ), LIMS, SDMS and Chromatography system would be added advantage.
• Knowledge of GXP validated environment is preferable.

Reference ID - GH/EPC/Senior Analyst - GTC GBS Finance