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