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Senior Regulatory Compliance – Lab Digitisation
EYSenior role assisting clients with Regulatory Compliance through LIMS implementations and configurations. Collaborating with teams and driving project deliverables while ensuring regulatory compliance.
About the role
Key responsibilities & impact- Help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies
- Establish, maintain and strengthen internal and external relationships
- Drive projects to completion with high quality deliverables
- Achieve operational efficiency and proactively identify and raise risks with the client and EY management
- Support validation and compliance activities by preparing configuration documentation, executing IQ/OQ/PQ, and ensuring adherence to 21 CFR Part 11, ALCOA+ data integrity principles
- Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations
- Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms
- Identify opportunities for automation and process improvement within laboratory operations using LIMS
Requirements
What you’ll need- B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry)
- 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries
- Good interpersonal skills; Good written, oral and presentation skills
- Ideally, you’ll also have Information Security (ISO 27001) or Risk Management certifications
- LIMS admin certification or Equivalent
- Certified Scrum Master (CSM) or Equivalent (Preferred but not required)
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
configuration documentationIQ/OQ/PQ executiondata migrationsystem configurationautomationprocess improvementlaboratory operationsdigital lab solutionsLIMS
Soft Skills
interpersonal skillswritten communicationoral communicationpresentation skillsrelationship management
Certifications
B.E/B.TechPostgraduate in ScienceInformation Security (ISO 27001)Risk ManagementLIMS admin certificationCertified Scrum Master (CSM)