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Senior Regulatory Compliance – Lab Digitisation – BA
EYSenior role in Regulatory Compliance focusing on LIMS implementations for Life Sciences industries. Collaborating with stakeholders to optimize laboratory workflows and meet business objectives.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
LIMSmaster data configurationsystem validationtestingdocumentationSQLscriptingautomation toolsanalytical techniqueslaboratory instrumentation
Soft Skills
communicationcollaborationproblem-solvinganalytical thinkingrisk assessmentimpact analysisbusiness process mappingworkflow optimizationtroubleshootingliaison
Tools & Technologies
SAPELNMESDocumentumTrackWiseVeeva VaultValGenesisEnterprise IT applicationslaboratory workflowssample lifecycle management
Industry Keywords
regulatory compliancelife sciencespharmaceuticaldata integrity principlesbusiness analystsystem administratormaster data managerBig 4multi-nationalpostgraduate in science
Tech Stack
Tools & technologiesSQLVault
About the role
Key responsibilities & impact- Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements.
- Gather and analyse business requirements related to LIMS functionality and enhancements.
- Translate business needs into functional specifications and system configurations.
- Configure, test, and validate LIMS functionalities to meet business needs.
- Conduct impact analysis and risk assessments for LIMS changes and enhancements.
- Serve as a liaison between business users and technical teams to ensure effective communication and system alignment.
- Participate in business process mapping and workflow optimization to enhance LIMS utilization.
- Assist in troubleshooting, identifying, and resolving LIMS-related issues.
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
- Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles.
- Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards.
- Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS.
- Hands-on experience in master data configuration within LIMS platforms.
- Experience in system validation, testing, and documentation.
- Exposure to Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization
- Understanding of relational databases and SQL queries.
- Experience with scripting or automation tools for LIMS is a plus.
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