Senior Business Analyst - LIMS
Role : Sr. Business Analyst-LIMS
Role Band : Violet/Indigo
Reporting to : Principal-Quality Solutions
Location : Hyderabad
Key Responsibilities :
- Execute tasks and producing deliverables as outlined in the Project Plan.
- Coordinate and support for project phase activities at rollout sites as per defined in rollout validation plan.
- Effectively and accurately communicate relevant project information to the end users.
- Contribute to overall project objectives and specific deliverables.
- Review of validation documents.
- Preparation and review of risk assessment and control activities.
- Review of relevant SOPs and coordinate with respective department to revise the SOP if required.
- Acting as SME for technical aspects related to functionalities for application.
- Support Instrument Engineer and vendor for Instrument template creation and finalization.
- Analyse issues and queries raised by end user or any system bug observed in running application.
- Review and confirmation of release note send by vendor for any issues or requirements.
- Support for evaluation, verification and testing of any patch updated in the application.
- Training to the concern team members related to LIMS application and relevant SOPs.
- Responsible for testing, followed by operational qualification for application changes.
- Responsible for active participation in executing validation activities such as IQ, SAT and UAT at rollout sites.
- Support for Master Creation.
Skill Required :
- Hands on experience in LIMS implementation (Labware/Labvantage/Thermo Fisher LIMS experience is preferable)
- Familiar with configurations (LIMS Masters and CDS interface)
- Familiar in writing the parser logics for instrument interface
- Familiar with LIMS-SAP interface functionality
- Able to troubleshoot the routine issues (application & Interface)
- Need to interface with QC, QA, IT, Global Quality for various activities.
Operating Network : QA / Production/ Warehouse/ Engineering/IT-BPE
Educational Qualifications & Experience : M.Sc./B. Pharm with 3- 8 years of experience in Quality Control Laboratory.
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