SrConsultant – life sciences it quality
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 mannerDeloitte 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, etcWork you will do being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to it qualityYou will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submissionThis is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on part 11 compliance of erp systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etcThe position provides excellent opportunity to:
Identify and manage regulatory risks to support client in regulatory compliance, governance and controls
Lead and coordinate cross-functional project teams for new product development and other validation projects to include reviews, risk analysis and other qa activities in support of systems development and manufacture
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
The team deloitte`s r&or life sciences and healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (gxp, part 11) and, governance and control of process, people and technologyR&or lshc practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruptionQualifications and experience 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
In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processesUnderstanding of risk management and its application in design and quality systems.
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Requisition code: 52451
Posted 30+ days ago
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