Deloitte Hiring Consultant / Senior Consultant – IT Quality Apply Now Bachelor’s degree (or equivalent)
Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc.
- Assist client in developing strategies for process improvement which caters to the needs of the quality organization
- Author validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)
- Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training
- Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)
- Review and approve validation lifecycle documentation
- Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions
- Provide Quality review and assessment of associated change requests related to processes, IT infrastructure, equipments and computer systems
- Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management.
- Initiate trainings and workshops for knowledge transfer and competence building
Required
- Bachelor’s degree (or equivalent)
- 5+ years of experience in pharma or medical device industry with a focus on quality and regulatory compliance
- Experience in systems validation and quality frameworks
- Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall)
- Hands on project management skills managing medium to large projects with end-to-end validation experience
- Clear understanding of principles, procedures and governance of validation activities.
- Demonstrated analytical and problem solving skills
- Demonstrated ability to create and direct proposal, and presentation effort
- Excellent written and oral communication skills.
- Motivation and skills to work in a team-oriented environment and a desire to work in a company that places a high value on cooperation and group achievement
Preferred:
- Master’s Degree
- In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems.
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