Regulatory Compliance Senior - Lab Digitisation

Responsibilities

• Gather and document LIMS requirements by working closely with business stakeholders, laboratory personnel, and IT teams.
• Analyze laboratory workflows and processes to recommend, implement, and configure LIMS solutions.
• Translate business needs into functional specifications and perform system validation and testing.
• Configure master data elements including test methods, sample types, specifications, and workflows.
• Integrate LIMS with enterprise systems such as ERP, ELN, CDS, and MES.
• Provide technical support, troubleshooting, and end-user training to ensure minimal system downtime.
• Ensure all system configurations and processes comply with industry standards like FDA 21 CFR Part 11 and EU GMP Annex 11.

Requirements

• B.E/B.Tech in Computer Science, Life Sciences, Chemistry, IT, or a related field, or a Postgraduate degree in Science.
• 5-8 years of experience in Regulatory Compliance or within the Life Sciences/Pharmaceutical industries.
• Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, or SampleManager).
• Strong understanding of GLP, GMP, and ISO 17025 compliance.
• Solid understanding of relational databases and SQL queries.
• Experience in system validation, testing, and technical documentation.

Preferred Qualifications

• Information Security (ISO 27001) or Risk Management certifications.
• LIMS administrator certification.
• Certified Scrum Master (CSM) designation.
• Experience with scripting or automation tools for LIMS.

Benefits

• Support, coaching, and feedback from experienced colleagues.
• Opportunities to develop new skills and progress your career through individual progression plans.
• A flexible working environment that allows you to handle your role in a way that works for you.
• Exposure to inspiring and meaningful projects within a global, multi-disciplinary team.

About the Company

EY is a global leader in assurance, consulting, tax, strategy, and transactions. We are dedicated to building a better working world by creating long-term value for clients, people, and society through the use of data, AI, and advanced technology.