Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise.

- Experience working in a GMP environment, 7+ 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)
- Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements.
- Comprehensive understanding of Quality Management processes, regulatory compliance, and industry standards.
- Certification in Trackwise or Equivalent Experience is required.
- Strong leadership skills with the ability to manage and mentor a team of analysts and developers.
- In-depth knowledge of Quality Management business processes within a regulated workplace, including CAPA/Deviation, Lab Exception, Audit, Product Complaints, and Supplier Management
- Extensive knowledge of Trackwise and other QMS modules,



with additional familiarity with ERP, SCM, and PLM systems.
- Exceptional oral and written communication skills, with the ability to conduct effective presentations, facilitate workshops, and negotiate with stakeholders.
- Excellent organizational and prioritization skills, capable of managing multiple projects and tasks in a dynamic environment.
- Proven ability to handle multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support.
- Experience in all phases of the project life cycle from analysis and design to implementation and testing, with a focus on business process improvement and optimization.
- Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions.
- Strong team player with excellent collaboration skills, fostering a positive team setting.
- Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment

📌 Platform Technical Lead - Trackwise (India)
🏢 Teamlease Digital Private
📍 India