ELN Domain Expert
- Amplelogic
- 4 - 9 years
- Hyderabad
- 9 days ago
- Email to a friend
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Job Description
Job Title: ELN Domain Expert
Preferred: Immediate joiners
Role Purpose
To provide subject matter expertise on laboratory processes and ensure the Electronic Lab Notebook (ELN) system is designed and used as per real lab workflows and compliance requirements.
Key Responsibilities
1. ELN Process Understanding
- Understand and define how experiments are performed in ELN:
- Experiment setup
- Data recording
- Calculations
- Review & approval
- Convert manual/paper-based lab records into ELN workflows
2. Requirement Support
- Work with IT / ELN configuration team to:
- Explain lab requirements
- Review ELN templates and workflows
- Support preparation of:
- User Requirements (URS)
- BRD / FRD
3. ELN Template & Workflow Review
- Review and validate:
- ELN templates (experiment forms)
- Data fields and calculations
- Workflow steps (draft review approval)
- Ensure templates are user-friendly and compliant
4. Compliance & Data Integrity
Ensure ELN usage follows:
- 21 CFR Part 11
- EU Annex 11
- ALCOA+
Focus on:
- Audit trails
- Electronic signatures
- Data traceability
5. Testing & Validation Support
- Participate in:
- UAT (User Acceptance Testing)
- Validate:
- ELN workflows
- Data capture accuracy
- Report issues and suggest improvements
6. Documentation Review
- Review:
- SOPs related to ELN usage
- Work instructions
- Ensure documentation matches actual ELN process
7. Training & User Support
- Train lab users on:
- How to use ELN
- Best practices for data entry
- Provide support during:
- Implementation
- Go-live phase
8. Continuous Improvement
- Identify:
- Gaps in ELN usage
- Inefficient workflows
- Suggest:
- Template improvements
- Process simplification
Required Skills:Domain Knowledge, Experience of ELN
Regulatory Knowledge, Soft Skills.
Please share CVS to pr******g@am*******c.com
Job Classification
Industry: Software ProductFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality ConsultantEmployement Type: Full timeContact Details:
Company: AmplelogicLocation(s): Hyderabad
Keyskills: Labware Lims Eln Documentation validation Life Sciences
Amplelogic
AmpleLogic is a leading product company with strong focus in Life sciences domain. Established in 2010, Amplelogic delivers applications 10X faster with 98% success Rate with their Award Winning Low Code Platform
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