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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.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
configuration documentationIQ/OQ/PQ executiondata migrationsystem configurationautomationprocess improvementlaboratory operationsdigital lab solutionsLIMS
Soft Skills
interpersonal skillswritten communicationoral communicationpresentation skillsrelationship management
Tools & Technologies
LIMSenterprise platforms
Certifications & Qualifications
B.E/B.TechPostgraduate in ScienceInformation Security (ISO 27001)Risk ManagementLIMS admin certificationCertified Scrum Master (CSM)
Industry Keywords
regulatory compliancelife sciencespharmaceutical21 CFR Part 11ALCOA+ data integrityBig 4multi-national
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