Job Details

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.

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

Reference ID - Manager - Infotech (applications - R & D)