Title:- Consultant – 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 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. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You 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/submission. This 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, etc.
The 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 projectsto 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 qualityorganization
- Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory)
- Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training
- Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith 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 timelyclosures 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 technology. R&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 disruption.
Qualifications and experience
Required:
- Bachelor’s degree (or equivalent)
- 2.5 -4.5 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.
About Deloitte
Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms,
and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”)
does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that
operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the
rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms.
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- 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 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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