Junior Manager-Quality Assurance

Job Description

Designation: Junior ManagerJob Location:BangaloreDepartment:Internal quality audits and continuous improvement (Quality)

• Computer System Validation wrt Learning Management System
• Perform Computer System Validation and support implementation of periodic update and other enhancements of Successfactors learning management system (LMS).
• Provide guidance to the implementation team during qualification/validation. Resolving any discrepancy raised during validation
• Involve in the CSV project for URS, FRS, GAP analysis, validation plan, Qualification plan, including IQ/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 | GxP Assessment | 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 of the investigations, review of deviations, CAPA.
• Act as a SME and SPOC wrt Successfactors Learning Management System (LMS) during 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.
• 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 compliance with the Learning management system and Syngene s training procedure and policy.

Key ResponsibilitiesYou will need to handle below mentioned activities.

• Perform Computer System Validation and support implementation of periodic update and other enhancements of Successfactors learning management system (LMS).
• Provide guidance to the implementation team during qualification/validation. Resolving any discrepancy raised during validation
• Involve in the CSV project for URS, FRS, GAP analysis, validation plan, Qualification plan, including IQ/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 Storyline during 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 compliance with the Learning management system and Syngene s training procedure and policy.

Educational Qualification:

• Science/ Technology/ Pharmacy graduatewith minimum 5 + years of working experience with Pharmaceutical / Life science

Technical/functional 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 yearsBehavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, persuasive and influencing 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, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
equal employment opportunitytroubleshootingcommitment towards worksafetymechanicalsapcommissioningcomputer system validationend user trainingstatements of work sow