Roles & Responsibilities

1. Design, create master data and execute dry runs for verification.
2. Design logics and verification through dry runs.
3. Investigation, addressing master data revisions and acknowledging the changes through ticketing system and as per change control action plan.
4. Ability to do process mapping & Gap identification in the existing process flows.
5. STP/SOP’s revision as per the LIMS requirements.
6. Execution of test scripts to enable qualification of instruments & new modules.
7. Effective communication with end users, CFT’s, line QA regarding the master data.
8. Lead the investigation, complete the root cause analysis, assess the impacted master data and propose an appropriate CAPA.
9. Periodic uptake of queries from end users and co-ordinating within the team members for resolutions.
10. End user training & support.
11. Support in regulatory audits.