Deloitte Hiring Pharma Consultant - Candidates Apply Online

Deloitte Hiring Pharma Consultant – Candidates Apply Online

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.

Job Title: Sr. Consultant – IT Quality

Location: Deloitte US GLS India Hyderabad, Andhra Pradesh, US GLS India

Eligibility Criteria:

  • Bachelor’s degree (or equivalent)
  • 5+ years of experience in the 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.

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 an excellent opportunity to:
  • Identify and manage regulatory risks to support the 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, equipment, 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 training and workshops for knowledge transfer and competence building

Apply Online

Editors Note: Deloitte Hiring Pharma Consultant Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.

LEAVE A REPLY

Please enter your comment!
Please enter your name here