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Job Description
- Lead validation efforts for GxP systems using a risk-based approach aligned with GAMP 5 and System Development Life Cycle (SDLC).
- Define CSV strategy, perform software classification, IT risk assessments, and develop mitigation plans.
- Conduct gap assessments and remediation for legacy systems to align with lifecycle validation principles.
- Oversee business process transformation initiatives involving systems like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, and RIMS.
- Troubleshoot IT application issues and provide strategic recommendations in collaboration with stakeholders.
- Author and review validation deliverables URS, FRS, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Final Reports.
- Ensure documentation meets internal SOPs and external regulatory expectations.
- Maintain audit-ready documentation and ensure data integrity throughout the system lifecycle.
- Act as Subject Matter Expert (SME) during internal audits and external inspections; address findings and implement CAPAs.
- Stay current with evolving regulatory guidelines and industry best practices.
- Collaborate with clients to develop validation strategies that meet engagement objectives and compliance standards.
- Drive business development activities, proposals, and client engagement strategies.
- Create innovative insights and contribute to thought leadership and knowledge-sharing initiatives.
- Manage periodic reviews, revalidation, and system retirement activities to ensure validated state.
- Review project status updates and prepare management presentations.
- Provide training, mentoring, and cross-skilling of project resources.
- Foster teamwork and a positive learning culture across service lines.
- Bachelor s or Master s degree in Life Sciences, Engineering, or related field.
- 8 12 years of experience in CSV within the pharmaceutical industry or consulting environment, with 3 5 years in a leadership role.
- Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, and Annex 11.
- Hands-on experience with regulated systems such as SAP, LIMS, MES, ELN, Veeva Vault.
- Excellent communication, documentation, and stakeholder management skills.
- Expertise in CSV documentation URS, FRS, IQ/OQ/PQ, Traceability Matrix, Validation Plans.
- Risk assessment & software classification for IT systems.
- Gap analysis & remediation for legacy systems.
- Audit readiness and experience supporting regulatory inspections.
- Hands-on experience with SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, RIMS.
- Familiarity with AI/ML model lifecycle.
- Understanding of data integrity principles and electronic records/e-signatures compliance.
- Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs).
- Proven ability to mentor junior staff and lead validation teams.
- Strong project management and client-facing skills.
- Experienced in Agile Projects and CSM certification is mandatory
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- Exposure to business development activities and client engagement strategies.
- Ability to create innovative insights and contribute to thought leadership.
- Experience in process optimization and operational efficiency initiatives.
- Ability to align technology with business transformation goals.
- High attention to detail and analytical thinking.
- Adaptability to changing regulatory and business environments.
- Strong problem-solving and decision-making abilities.
- Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA).
- ISO 90012015 Lead Auditor, Quality Auditor Certification (CQA).
- Information Security or Risk Management certifications.
Skills
SAPBusiness TransformationOperational ExcellenceProject ManagementAnalyticalConsultingLife SciencesGap AnalysisQuality AssuranceSoftware Quality AssuranceInformation SecurityIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
About Company
EY India Careers 2025 – Overview
Ernst & Young Global Limited (EY) is one of the Big Four professional services organisations, headquartered in London, England, and operating in 150+ countries with a global workforce of ~400,000 professionals.
EY’s roots trace back to 1849 (Harding & Pullein) and 1903 (Ernst & Ernst), with the current global legal entity formed in 1989 through the merger of Ernst & Whinney and Arthur Young.
In India, EY employs ~50,000–55,000 people across offices in Gurugram, Mumbai, Bengaluru, Hyderabad, Chennai, Kolkata, and Pune. The firm operates through four integrated service lines — Assurance, Consulting, Strategy and Transactions, and Tax — helping clients capitalise on opportunities, manage risk, and deliver responsible growth.
EY’s purpose, Building a better working world, guides its work with businesses, governments, and non‑profits to solve complex challenges. The firm is recognised for its investments in AI (via the EY.ai platform), digital transformation, sustainability, and inclusive growth.
Business Model
EY operates as a service‑based B2B professional services firm, generating revenue through assurance, consulting, strategy & transactions, and tax services.
Its model blends:
- Deep sector expertise with technology‑driven solutions
- Global delivery capabilities with India as a strategic hub
- Long‑term client relationships built on trust and recurring engagements
Strategic priorities for EY India include:
- Scaling EY.ai and AI‑enabled services
- Expanding ESG and sustainability consulting
- Strengthening cybersecurity and digital transformation offerings
- Growing Strategy and Transactions advisory in high‑growth sectors
Recent Wins & Recognition
- Launched the EY.ai platform to integrate AI into all service lines globally and in India (https://www.ey.com/en_in/news/2023/ey-launches-ey-ai-platform).
- Advised on a $1.1 billion renewable energy acquisition in India (https://economictimes.indiatimes.com/industry/energy/power/ey-advises-on-renewable-energy-acquisition/articleshow/).
- Recognised as a Leader in Digital Strategy Consulting in the 2025 IDC MarketScape report (https://www.ey.com/en_in/news/2025/ey-named-leader-in-digital-strategy-consulting).
- Partnered with the Government of India on Gati Shakti infrastructure planning (https://www.ey.com/en_in/news/2024/ey-supports-gati-shakti-infrastructure-planning).
- Awarded Best Employer for Women 2025 by Working Mother & Avtar (https://www.ey.com/en_in/news/2025/ey-best-employer-for-women).
Culture & Values
EY’s culture is anchored in its EY Values:
- People who demonstrate integrity, respect, and teaming
- People with energy, enthusiasm, and the courage to lead
- People who build relationships based on doing the right thing
The firm promotes diversity, equity, and inclusion, offers global mobility opportunities, and invests heavily in continuous learning through EY Badges, EY Tech MBA, and leadership programs.
Client‑Facing Businesses
Assurance
What it is – Independent audit and assurance services to enhance trust in financial reporting. Careers in India include:
- Statutory Audit – Auditing financial statements for listed and unlisted companies.
- Financial Accounting Advisory Services (FAAS) – IFRS/Ind AS advisory, reporting, and accounting change support.
- Forensic & Integrity Services – Fraud investigation, dispute resolution, and compliance reviews.
- Climate Change & Sustainability Services (CCaSS) – ESG reporting and assurance.
Consulting
What it is – Advises clients on business transformation, technology, and risk. In India, career opportunities span:
- Business Consulting – Strategy, operations, and supply chain transformation.
- Technology Consulting – ERP, cloud, data analytics, and cybersecurity.
- Risk Consulting – Enterprise risk, internal audit, and regulatory compliance.
- People Advisory Services – Workforce strategy, change management, and HR transformation.
Strategy and Transactions (SaT)
What it is – End‑to‑end deal advisory and capital strategy. India‑based roles cover:
- M&A Advisory – Buy‑side and sell‑side deal advisory.
- Transaction Diligence – Financial, tax, and operational due diligence.
- Valuation, Modelling & Economics – Business valuations and financial modelling.
- Restructuring – Turnaround and insolvency support.
Tax
What it is – Comprehensive tax and regulatory services. In India, career paths include:
- Direct Tax – Corporate and international tax compliance and planning.
- Indirect Tax – GST, customs, and trade advisory.
- Transfer Pricing – Planning, documentation, and dispute resolution.
- Tax Technology & Transformation – Automation and analytics for tax functions.
Important dates & deadlines?
Application Deadline
02 May 26, 03:41 PM IST
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