Job Title: Trackwise Consultant
Job Summary
The TrackWise Consultant will be responsible for providing expertise in the configuration, customization, and support of the TrackWise quality management system (QMS). The ideal candidate will work closely with business stakeholders, quality teams, and IT teams to understand business requirements, design solutions, and ensure effective implementation of TrackWise functionalities. This role involves managing quality processes, configuring workflows, and ensuring compliance with regulatory standards.
Key Responsibilities
- Configure and customize the TrackWise QMS to meet specific business requirements.
- Collaborate with stakeholders to gather and document functional requirements for TrackWise workflows, forms, and reports.
- Design and implement solutions that optimize quality and compliance processes within TrackWise.
- Conduct system testing, validation, and provide support for system upgrades, enhancements, and troubleshooting.
- Develop and maintain system documentation, including configuration guides, test scripts, and user manuals.
- Provide training and support to end-users, ensuring they are equipped to use TrackWise effectively.
- Ensure compliance with industry regulations (e.g., FDA, GMP, ISO) and organizational policies related to quality management.
- Work with IT teams to integrate TrackWise with other enterprise systems as required.
- Stay updated on TrackWise product updates and industry best practices to enhance system functionality and performance.
Qualifications
Education: Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or related field.
Experience
- 6+ years of experience with TrackWise QMS software.
- Strong experience in configuring and customizing TrackWise modules like CAPA, Change Control, Deviations, and Complaints.
Skills
- In-depth knowledge of TrackWise configuration, workflow design, and integration.
- Strong understanding of quality and compliance regulations, such as FDA, GMP, and ISO standards.
- Excellent problem-solving skills and the ability to analyze and resolve technical issues.
- Strong communication skills with the ability to translate technical solutions into business terms.
- Ability to work independently and as part of a cross-functional team.
Preferred
- TrackWise Certification or similar credentials.
- Experience in the pharmaceutical, medical device, or biotechnology industries.
- Familiarity with ITIL processes and project management methodologies.