ITQA

Focuses on ensuring the quality, compliance and operational efficiency of IT systems. Acting as the interface between IT and the Business, ensuring correct interpretation of the business requirements and supporting the handling and management of QMR, Quality Documentation, Quality Records i.e. ChangeControl, CAPAs and Deviations. Work with Business Process Owners to determine viable solutions and enhancements for business software system issues.

Business Analyst / Business Systems Analyst

The role of a business systems analyst, or systems analyst is to oversee business systems, gather and analyse information or data, business processes, requirements and determining where to make improvements. These highly analytical specialists have both business and technical expertise. They work with management and end users to gain an understanding of how the enterprise system(s) works and how it could work better. They oversee how each new requirement or piece of functionality fits into the overall business process and generate enterprise systems standard operating procedures (SOPs).

Business Process Specialist

Research, analyse, and recommend changes to an organization’s business processes to improve operational efficiencies and quality. They ensure the business operates smoothly and efficiently by collecting performance data to identify trends, process weaknesses and opportunities to improve and taking a pivotal role in driving continuous improvement to the development process through automation and process simplification.

Service Delivery Manager

Ensure services are delivered seamlessly to the business. They perform a variety of tasks technical and administrative, such as solving technical problems, tracking KPIs, and controlling service quality. Ultimately, the service delivery manager works to maintain good customer relationships and improve the company’s services to maintain customer satisfaction. They do this through communication with the customer, identifying and evaluating customer issues and needs by maintaining an excellent relationship with end-users and stakeholders. Provides leadership and coaching support to the project teams. Providing accurate and regular reports to the management on service delivery performance.

Informatics Consultant

Evaluate and improve the systems used to collect, configure, and analyze data in the laboratory environment and then identify ways those systems can be better utilized to solve a problem or improve the solution. Develop and customize systems to better use data by working collaboratively with stakeholders and end users to determine their needs and objectives and provide strategic direction to the IT, Scientific, and Management teams.

QA Consultant / Lead Auditor

Examine the quality of processes, products and services, identify any issues and determine how best to resolve them. In conducting and supporting audit readiness they are responsible for leading the audit team, preparing the audit plans and submitting audit reports. This involves but is not limited to conducting interviews with company employees to gather information about internal controls, risk management procedures, and other critical aspects of the company’s operations. As required, they will inspect a client’s physical facilities to assess risk exposures and compliance with industry standards. Review company policies and procedures for compliance to regulations. Prepare detailed reports of findings and recommendations for corrective action.

Technical Writer

Understand and communicate complex products, training and documentation by creating user-friendly content that meets the target audience’s needs. They are skilled at writing for both a technical and non-technical audience in a way that is engaging and can be clearly understood by the reader. They will write, format, edit, facilitate review and proof both procedural and technical documents.

Organisational Change Manager

Partner with Executive Leadership to design and develop Organizational Change Management (OCM) strategy and associated communications approach at a program level. Develops and sustains strong working relationships with Program Management to ensure a holistic approach to change and consistency of messaging. Leverages best-in-class OCM processes, core methodologies, templates, practices and tools, ensuring alignment to Program strategy. They will have oversight of all internal communications to ensure consistent messaging across all projects.

Enterprise Solution Architect

Create the overall design and technical vision to solve identified problems within the business. They establish and maintain strong relationships and gain knowledge of business functions and enterprise systems to understand business activities and business drivers, business requirements and solutions strategies to ensure the successful implementation/integration of the organization’s enterprise systems and programs. They translate the business vision into user requirements and support the project team through the project lifecycle

CSV Consultant

Provide computer system validation leadership on multiple complex technical projects with a high strategic impact. They provide industry knowledge, technical competency, critical support and pragmatic solutions to allow for risks and issues resolution, on-time project delivery, and full integration with the clients. Responsible for providing consulting on computer system validation on GxP systems to ensure compliance with all applicable regulations, including FDA’s GLP and GMP/Part 11 and EU Annex 11 and industry guidelines such as ISPE GAMP5, MHRA’s GxP Integrity Guidelines, and GDPR. Oversee the generation of validation documentation and ensure best validation and test practices are employed across the company to maximize effectiveness and minimize nonvalue-adding work