Looking for CSV IT role- BLR/HYD/GUR

Regulatory & Risk Management | Regulatory & Legal Support
Same job available in 3 locations

Position Summary

Work you will do

Being part of our team, you are responsible for specific 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 reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires hands on experience on Part 11 compliance of computerized systems. The position provides excellent opportunity to:

·       Work with the lead to identify regulatory risks and appropriate remediation

·       Work in 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 the lead in developing strategies for process improvement which caters to the needs of the quality organization

·       Review validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)

·       Execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)

·       Review validation lifecycle documentation

·       Work with the lead to review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions

·       Provide Quality review and assessment of associated change requests related to computer systems

·       Provide progress updates of the assigned deliverables and escalate issues to the lead appropriately

·       Participate in 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)
  • 3+ years of experience in pharma or medical device industry with a focus on quality and regulatory compliance
  • Experience in systems validation
  • Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall)
  • Clear understanding of principles, procedures and governance of validation activities.
  • 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.

How you will grow

At Deloitte, we have invested a great deal to create a rich environment in which our professionals can grow. We want all our people to develop in their own way, playing to their own strengths as they hone their leadership skills. And, as a part of our efforts, we provide our professionals with a variety of learning and networking opportunities—including exposure to leaders, sponsors, coaches, and challenging assignments—to help accelerate their careers along the way. No two people learn in exactly the same way. So, we provide a range of resources, including live classrooms, team‑based learning, and eLearning. Deloitte University (DU): The Leadership Center in India, our state-of-the-art, world-class learning center in the Hyderabad offices, is an extension of the DU in Westlake, Texas, and represents a tangible symbol of our commitment to our people’s growth and development. Explore DU: The Leadership Center in India

Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

Deloitte’s culture

Our positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer well-being programs and are continuously looking for new ways to maintain a culture that is inclusive, invites authenticity, leverages our diversity, and where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte.

Corporate citizenship

Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships with our clients, our people, and our communities. We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world.



Our people and culture

Our diverse, equitable, and inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our client most complex challenges. This makes Deloitte one of the most rewarding places to work. Learn more about our inclusive culture.

Professional development

From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Learn more about our commitment to developing our people.


Requisition code: 46555

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