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Ernst & Young

Global professional services: consulting, assurance, tax

Consultant - Business Consulting Risk, Tmt, Cns, Risk, Digital Risk, Mumbai

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeMumbai, Maharashtra, IndiaNo salary listedIn-person

About the Job

Requirements

  • Bachelor of Technology in Computer Science, B Pharmacy, or Bachelor of Computer Applications.
  • Two to thirteen years of computer system validation experience.
  • Experience in Quality and Compliance with hands-on computer system validation on enterprise applications such as LIMS, ERPs, LMS, RPA, and CTMS.
  • Experience in an FDA-regulated environment with understanding of cGxP standards, including cGMP, cGDP, cGAMP, and cGLP, and risk-based validation.
  • Ability to work collaboratively across multiple client departments while following commercial and legal requirements.
  • Practical problem-solving ability to deliver insightful and practical solutions; adaptability and creativity.

Responsibilities

  • Perform assessments of computer systems and processes for Life Sciences clients for compliance with internal procedures, leading practices, and regulatory requirements.
  • Create and review CSV deliverables, including user requirements, system specifications, validation plans, qualification plans, standard operating procedures, IQ/OQ/PQ, traceability matrices, design specifications, and validation summary reports.
  • Provide guidance and oversight of validation activities for projects involving GxP-relevant computer systems.
  • Work with project team members to incorporate appropriate quality and compliance elements into the system lifecycle.
  • Review and approve computer system validation work products, ensuring thorough validation planning and progress toward timely completion of validation deliverables.

Desired Qualifications

  • Experience with validation or testing tools such as HP ALM and Azure DevOps is an added advantage.
  • Experience training validation resources is an added advantage.

About the Company

Ernst & Young

Global professional services: consulting, assurance, tax

EY (Ernst & Young) provides professional services at a global scale, offering consulting, assurance, tax, and transaction advisory services. It serves clients across industries such as technology, media, real estate, hospitality, and construction. Instead of selling a single product, EY works with clients through tailored engagements where cross-disciplinary teams analyze challenges, design strategies, perform audits, help with tax planning, and assist with mergers or divestitures. What sets EY apart is its worldwide reach and integrated service model, industry-specific expertise, and focus on responsible business practices like sustainability, cybersecurity, and workforce flexibility. EY’s goal is to help organizations improve performance, manage risk, and achieve sustainable growth while building a better working world.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Boston, MA
Founded
1991

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