Associate

Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Associate Job Description & Summary A career within Internal Audit services, will provide you with an opportunity to gain an understanding of an organisation’s objectives, regulatory and risk management environment, and the diverse needs of their critical stakeholders. We focus on helping organisations look deeper and see further considering areas like culture and behaviours to help improve and embed controls. In short, we seek to address the right risks and ultimately add value to their organisation.

JOB DESCRIPTION – QMS TrackWise and Caliber Position Title Associate/Sr. Associate Location Mumbai Department QMS TrackWise and Caliber – Risk Consulting Grade Associate Purpose of the Job /Role ● Technical Design, Development, Testing and Delivery of solutions for Release Cycles and/or new projects within TrackWise and Caliber. ● Work with project managers, business stakeholders, architects, and other development team members to gather requirements. ● Identify opportunities to improve the systems process flow, performance, and technical efficiencies. ● Development and implementation of TrackWise and Caliber integration with external systems like SAP, LIMS, etc. ● Work in support processes like Incident management, Change management, Problem management. ● Installation and upgrade of TrackWise and Caliber QMS system from on-premise to cloud infrastructure Skill Profile  To configure Process Groups and harmonized workflows specific to QMS Processes.  Experience in TrackWise, Caliber configurations (Designing workflows, TrackWise coordinator Admin queries, Dynamic queries, Admin triggers, Notifications).  Technical Support for implementation & Operations of e-QMS i.e., TrackWise, Caliber for Quality Management Systems  Knowledge of using TrackWise import utilities. (PR, Selection, entity, Person)  Ability to troubleshoot integrations with other systems.  Good technical knowledge in Database and Crystal Reports design.  Hands on with TrackWise Quality modules like Team Access, Web Admin, Coordinator, Migrator  Experience working in business requirement customization using webservices.  Familiar with Business processes like Complaint, Deviation, Audit, CAPA, OOS/OOT, Investigation, Non-conformance, etc.  Any new initiatives for continuous improvement of Quality Systems to enhance compliance.  To Create and Manage User Accounts, Access Levels, User Roles, Desktop Search Classes.  Support business requirements analysis, perform Impact analysis and risk assessment and Proficient in analyzing User Requirements Specification, Functional Specification, Software Design Specification, Process flow diagrams, test plans, test scripts and Validation documentation (IQ/OQ/PQ) etc.  End to End Computer System Validation knowledge for QMS TrackWise, Caliber implementation.  Knowledge about compliance environments like pharmaceutical/Healthcare industries and exposure on differently regulatory guidelines like 21 CFR part 11, Annexure 11 EMEA and GAMP5 etc Roles & Responsibilitie s ● Installation & Configuration of TrackWise and Caliber Components and performing TrackWise version upgrades & migration. ● Crystal report development (Single and Multi) ● Responding to support calls for production environment in order to make quick repair to keep application in production. ● Execution of the process configurations and comply with process and data standards. ● Provide solutions for the integration of other external system for upstream and downstream. ● Investigate Problem and incidents related to applications and ensures appropriate action by providing enhancement services and documentation Years of 3-5 years Experience Education B.Tech / M.Tech / BCA / MCA/ B.Sc / M.Sc Other Competencies ● Knowledge on Veeva Vault and TrackWise digital ● Good Documentation skills. ● Collaborate with other team members and stakeholders. ● Strong written and oral communications, analytics, and organization skills ● Self-motivated, goal oriented, and an innovative thinker ● Maintain strong analytic, technical, and troubleshooting skills.

Mandatory Skill Set- SAP Preferred Skill Set- LIMS Year of experience required- 2 Qualifications- B.Tech

Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required:

Degrees/Field of Study preferred: Certifications (if blank, certifications not specified)

Required Skills

Optional Skills

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Available for Work Visa Sponsorship?

Government Clearance Required?

Job Posting End Date