Job Title: Project Change Management Specialist
About the Role:
The Project Change Management Specialist is a critical role that ensures the smooth execution of change control activities for site projects. This individual will be responsible for managing changes related to processes, equipment, automation, and supply chain, as well as other technical functions. The specialist will work closely with stakeholders to identify and implement process optimization opportunities, align system release strategies, and maintain accurate task scheduling.
Key Responsibilities:
- Ownership and management of changes associated with large strategic projects
- Preparation and progression of GMP and Non-GMP changes in IPI, Vault QMS, and Enablon systems
- Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups through the life cycle of relevant changes
- Obtain approval for change from relevant review board
- Impact assessment for relevant changes
- Liaise with stakeholders for impact assessment and task identification
- Aligning of system release strategy with stakeholders/operations
- Identification and implementation of process optimization opportunities where they arise
- Maintaining accurate task scheduling per project requirements
- Minimizing the number of overdue tasks through schedule management
Core Competencies:
Technical Skills:
- Understanding of unit operations and plant equipment
- Understanding of validation (process and cleaning)
- High-level understanding of regulatory requirements as they relate to change control
- Understanding of quality policies and procedures
- Understanding of GMP and GDP practices
- Knowledge of safety and environmental procedures
- Proficiency in using digital systems for full digitalization change control execution
Business Acumen:
- Excellent communication skills, both oral & written
- Project management skills
- Data collation skills
- Decision-making and problem-solving skills
Leadership Qualities:
- Customer service skills
- Collaboration skills
Educational Requirements:
- Ideally candidates should have a strong emphasis on change control documentation, a GMP/GDP background, and a degree in a science and/or engineering-based discipline
- Minimum of 3-8 years' experience
- Experience of working in a project environment
- Hands-on attitude, specifically carrying out change controls to a very high standard
Required Skills and Qualifications:
- Change control
- QMS
- GMP