Role
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.
Preferred: immediate joiners only
Please share CVS to [Confidential Information]
