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LMS Administrator

3 months ago

Bengaluru, India Syngene Full time

Designati on:
Assistant Manager
Job Locati on:
Bangalore
Department:
Internal quality audits and conti nuous improvement (Quality)
Job Descripti on:
Computer System Validation wrt Learning Management System
Perform Computer System Validation and support implementation of periodic update and otherenhancements of Successfactors learning management system (LMS).
Provide guidance to the implementation team during qualification/validation. Resolving any discrepancyraised during validation
Involve in the CSV project for URS, FRS, GAP analysis, validation plan, Qualification plan, includingIQ/OQ/PQ preparation/execution. Preparation of traceability matrix & Validation summary report preparation.
Follow GAMP-5 risk based approach and complete life cycle approach of computer system validation.
Computer System Validation | IT Compliance for Life Sciences | Project Management | Gap Analysis | GxPAssessment | V Module life cycle.
Generate and Review validation deliverables like Validation Plans | Test criteria | Specifications (URS, FRS,FDS) | Risk Assessments (IRA, FRA) | Qualification Protocols (IQ, OQ, IOQ, PQ) | Traceability Matrix |Summary Reports.
Review of QMS, exposure to Change Control | Deviations | Discrepancy| CAPA management. Being a part ofthe investigations, review of deviations, CAPA.
Act as a SME and SPOC wrt Successfactors Learning Management System (LMS) during regulatory andclient’s audits.
Support to internal audit team to conduct the internal audit for Learning Management System.
Perform system hygiene check and ensure optimum utilization of LMS system in a compliant manner.
Verification of internal and external CAPA wrt CSV.
Provide end user training of Learning Management System and support users in the trouble shooting.
Create SCORM contents and train end users for content creation using Articulate Storyline soft ware.
Test and evaluate the SCORM contents created by external vendors for the functionality and compliancewith the Learning management system and Syngene’s training procedure and policy.
Key Responsibiliti es
You will need to handle below mentioned activities.
Perform Computer System Validation and support implementation of periodic update and otherenhancements of Successfactors learning management system (LMS).
Provide guidance to the implementation team during qualification/validation. Resolving any discrepancyraised during validation
Involve in the CSV project for URS, FRS, GAP analysis, validation plan, Qualification plan, includingIQ/OQ/PQ preparation/execution. Preparation of traceability matrix & Validation summary report preparation.
Follow GAMP-5 risk based approach and complete life cycle approach of computer system validation.
Generate and Review validation deliverables like Validation Plans | Test criteria | Specifications (URS, FRS,FDS) | Risk Assessments (IRA, FRA) | Qualification Protocols (IQ, OQ, IOQ, PQ) | Traceability Matrix |Summary Reports.
Act as a SME and SPOC wrt Successfactors Learning Management System (LMS) and Articulate Storylineduring regulatory and client’s audits.
Support to internal audit team to conduct the internal audit for Learning Management System.
Perform system hygiene check and ensure optimum utilization of LMS system in a compliant manner.
Provide end user training of Learning Management System and support users in the trouble shooting.
Create SCORM contents and train end users for content creation using Articulate Storyline soft ware.
Test and evaluate the SCORM contents created by external vendors for the functionality and compliancewith the Learning management system and Syngene’s training procedure and policy.
Educati onal Qualifi cati on:
Science/ Technology/ Pharmacy graduate
with minimum 5 + years of working experience withPharmaceuti cal / Life science
Technical/functi onal Skills:
High-level English Proficiency in read, write and communication
Hands on Experience in SAP Successfactors LMS and Articulate storyline software.
Thorough understanding of SAP Successfactors LMS and Articulate storyline software
Knowledge of project management.
Hands-on experience as learning administrator in Learning Management System (LMS)
Hands-on experience of facing regulatory audits as a SME for the training management.
Knowledge of Quality Management System
Knowledge of GxP and Data Integrity principles
Experience:
5 to 9 years
Behavioral Skills:
Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, persuasive andinfluencing ability in a team.
Good speaking-listening-writing skills, attention to details, proactive self-starter.
Ability to work successfully in a dynamic, ambiguous environment.
Ability to meet tight deadlines and prioritize workloads.
Ability to develop new ideas and creative solutions.
Should able to work in team.
Should be a self-motivated and focused employee.
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age,color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexualorientation, gender identity and/or expression, genetic information, marital status, status with regard to publicassistance, veteran status, or any other characteristic protected by applicable legislation or local law. Inaddition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.