Techno Functional Analyst - Trackwise

Bachelor's degree with over 8 years of experience in designing and developing solutions in Trackwise

Proven track record of successfully completing Trackwise project implementations, including stages such as discovery, design, development, testing, and deployment.

Experience working in a GMP environment, 5+ years in an IT Systems Role.

Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management.

SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP)

Familiarity with other enterprise systems and modules such as ERP, SCM, and PLM, which complement quality management functions.

Certification in Trackwise or Equivalent Experience is required.

In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA, Change Control, Audits, and Deviations.

Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems.

Strong oral and written communication skills, effective presentation and negotiation abilities, and experienced in managing multiple presentation scenarios.

Proven ability in handling multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support.

Experience in all phases of project life cycle from analysis and design to implementation and testing.

Excellent analytical, problem-solving, and interpersonal skills.

Strong team player with excellent collaboration skills.

Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment

Agile Methodology using Jira, creating Epics, and writing Jira Stories.