Job Description

Job Purpose

The purpose of this role is to ensure that Information Systems are validated and/or tested so as to best support the business within the financial budget constraints of the IT function. This will be achieved through the following activities:

• Project Validation Management
• Change Management
• Managed release to the business
• Communication
• Risk Management

Key Performance Areas

• Ensures that management processes, tools, techniques, and resources are in place to ensure that the transition of IT services, service components and packages are planned and compliant and that test and validation and configuration management are partnered in all release and deployment activities
• Sets the release policy, standards and procedures related to the planning, testing, validation, and release during implementation of new IT services
• Sets the standards and procedures for maintaining the validated state through managing changes to IT services in production
• In projects that result in the release of IT services ensures that projects, teams and functions have appropriate practices in place and are meeting required standards by controlling and managing the validation activities, resources and budgets
• Evaluates risks to the integrity of IT services inherent in proposed implementations and changes (including data integrity, patient safety and quality of the pharmaceutical product; and availability, performance, security and compliance of the impacted IT services)
• Ensures effective control and treatment of risk evaluated throughout the change and release lifecycles
• Leads the assessment, analysis, planning, verification and documentation of releases
• Leads the assessment, analysis, development, documentation and implementation of changes based on requests for change
• Leads the stage gate approval process in release management
• Liaises with business and IT partners on release scheduling and communication of progress
• Defends policies, procedures defining the validation, release and change management approach, as well as documentary evidence of execution during regulatory audits
• All validation related audit queries are followed up and resolved in the shortest possible time frame and within the policy framework while constantly updating the internal or external customers as to the progress
• Conducts post release reviews. Ensures release processes and procedures are applied and that releases can be rolled back as needed. Identifies, evaluates and manages the adoption of appropriate release and deployment tools, techniques and processes (including automation).
• Develops and implements continuous improvement plans to achieve and maintain compliance against national and international standards

Job Requirements

Educational qualifications & experience

Education

• Related Tertiary Qualification an advantage
• Related certification and/or registrations an advantage

Experience * Extensive IT Pharma Validation experience

• High level of computer literacy
• Experience and sound knowledge of service change and release management methodologies

Technical Competencies & Skills * Attention to detail, above average report writing skills

• Solid understanding of GAMP 5 guidelines
• Solid understanding of EU annex 11 and 15, FDA CFR Part 11 and PIC/s requirements for Computer System Validation in a regulated industry

Aspen Competencies

Business * Create the Future - Accountability/ Ownership

People * Communicate Effectively

• Dealing with ambiguity - Embrace Change

Self * Contribute Special Expertise

• Take Action with Integrity

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Aspen Pharmacare