IT Change, Release and GxP Validation Manager - Port Elizabeth at Aspen Pharma Group

Job Purpose

The IT Change, Release, and Validation Manager is responsible for ensuring that changes to IT systems and applications are managed in a controlled manner, minimizing risk to the business. This includes managing the release of IT systems and applications into production environments, ensuring that they are delivered in a controlled manner, and ensuring that IT systems and applications meet regulatory requirements through testing and validation activities. 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 Responsibilities:

• Manage the IT change management process, including Request for Change (RFC), change assessment, change approval, change implementation, and change review.
• Manage the IT release management process, including release planning, release build, release deployment, and release review.
• Manage validation activities for IT systems and applications, including validation planning, user requirements specification (URS), functional requirements specification (FRS), design specification (DS), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Ensure that changes to IT systems and applications are managed in a controlled manner, minimizing risk to the business.
• Ensure that IT systems and applications meet regulatory requirements through testing and validation activities.
• Ensure that computerized systems remain in a state of control throughout their lifecycle by managing changes through change control procedures and periodically reviewing computerized systems to ensure they continue to meet their intended use and remain in a validated state.

Requirements

Job Requirements

Educational qualifications & experience

• Bachelor’s degree in Computer Science or related field
• Minimum of 5 years of experience in IT change management
• Experience with GAMP5 guidelines
• Strong understanding of regulatory requirements for computerized systems

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 EU annex 11 and 15, FDA CFR Part 11 and PIC/s requirements for Computer System Validation in a regulated industry
• Change Management (Level 5): Ensuring that changes to IT systems and applications are managed in a controlled manner, minimizing risk to the business.
• Release and Deployment (Level 5): Managing the release of IT systems and applications into production environments, ensuring that they are delivered in a controlled manner.
• Validation (Level 5): Ensuring that IT systems and applications meet regulatory requirements through testing and validation activities.

Aspen Competencies

Business

• Create the Future - Accountability/ Ownership

People

• Communicate Effectively
• Dealing with ambiguity - Embrace Change

Self

• Contribute Special Expertise
• Take Action with Integrity