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Ernst & Young

Global professional services: consulting, assurance, tax

Senior Consultant - Business Consulting Risk, Tmt, Cns, Risk, Digital Risk, Bangalore

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

  • A graduate degree from a reputed university.
  • Bachelor of Technology in Computer Science or B.Pharm.
  • Three to thirteen years of overall computer system validation experience.
  • Hands-on experience with 21 CFR and computer system validation.
  • Experience in quality and compliance with hands-on computer system validation on enterprise applications such as laboratory information management systems, enterprise resource planning systems, learning management systems, robotic process automation, or clinical trial management systems.
  • Experience in an FDA-regulated environment and a good 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, including addressing complex problems and delivering practical solutions.
  • Ability to be adaptable and creative in the approach to work.

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 computer system validation deliverables, including user requirements, system specifications, validation plans, qualification plans, standard operating procedures, installation/operational/performance qualification protocols, traceability matrices, design specifications, and validation summary reports.
  • Provide guidance and oversight of validation activities for projects involving GxP-relevant computer systems.
  • Work closely 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 timely progress toward completion of validation deliverables.

Desired Qualifications

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

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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