Overview Exciting opportunity exists for a Change Control Lead, to join a highly skilled Project team, based on site in Tipperary, supporting a large-scale capital project.
Ideally candidates should have a strong emphasis on Change Control processes, a GMP/GDP background, and a degree in a Science and or Engineering based discipline.
The role will be responsible for the ownership and management of changes through the change control system.
Responsibilities.
The successful applicant will be responsible for initiation, ownership and management of changes through the change control system.
Collaboration with change initiators, subject matter experts, reviewers, approvers and external groups through the life cycle of relevant changes.
Liaising with project teams to enable schedule adherence as it relates to turnaround of changes.
Principal Accountabilities:
Ownership and management of safety, quality and environmental changes, as associated with large strategic projects.
Changes may be related to processes e.g.
equipment, automation, utilities and facilities, or other technical functions as required.
Initiation of changes, where deemed appropriate.
Impact assessment for relevant changes.
Collaboration with Change Initiators, SMEs, Reviewers, Approvers and other stakeholders to enable successful and efficient change progression.
Identification and implementation of process optimization opportunities where they arise.
(e.g.
Hierarchy or dependency optimization, material control strategies).
Maintaining accurate task scheduling per project requirements.
Minimizing the number of overdue tasks through schedule management.
Engagement with the Tier process to escalate changes or tasks that are off track.
Overall schedule management for change control lifecycle including metric and management reporting from multiple change control platforms.
Core Competencies Technical:
Good Knowledge/Experience managing Change Control System and proprietary software systems.
Understanding of unit operations and plant equipment.
Understanding of Commissioning, Qualification and Validation protocols (CQV) for process, equipment qualification and clean & black utilities.
Knowledge of Safety and Environmental procedures High level understanding of current regulatory environment and regulations/requirements as they relate to change control.
Understanding of Quality management system policies, documentation and procedures.
Understanding of GMP and GDP practices.
Proficiency in using digital systems for full digitalisation Change Control execution.
Familiar with project life cycle delivery.
Business:
Excellent communication skills, both oral & written.
Organisation and planning skills Meetings management skills Project management skills.
Data collation skills.
Decision making and problem-solving skills.
Interpersonal skills.
Leadership:
Customer service skills.
Collaboration skills.
Educational Requirements Qualifications Ideally candidates should have a strong emphasis on Change Control Documentation, a GMP/GDP background, Quality 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.
Excellent oral and written communication skills in English.
High level of customer orientation/understanding.
Time management (self) ability to deliver to timelines.
Attention to detail and knowledge of Safety, GMP and GDP requirements.
Skills:
Change Control CQV GMP QMS