Job Purpose:

Reporting to the Maintenance Manager, the Change Control Lead is responsible for achieving the deliverables involved in the planning and execution of all change control activities for the BACE project. The role is accountable for compliance with regulatory requirements, ensuring that the site meets all change control requirements and that systems are audit-ready for both customer and agency inspections. The incumbent promotes GMP awareness at the Ballydine site, providing feedback and training to the BACE team on improvements that can be made to enhance GMP and compliance as appropriate.

Key Responsibilities:

• Ownership and management of changes associated with large strategic projects. Changes may be related to processes such as equipment, automation, and supply chain, or other technical functions as required.
• Responsible for initiation, ownership, and management of changes through the change control systems.
• 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 throughout the life cycle of relevant changes.
• Obtain approval for change from the relevant review board.
• Impact assessment for relevant changes.
• Liaise with stakeholders for impact assessment and task identification.
• Align system release strategy with stakeholders/operations.
• Identify and implement process optimization opportunities where they arise (e.g., hierarchy or dependency optimization, material control strategies).
• Maintain accurate task scheduling per project requirements and minimize the number of overdue tasks through schedule management.
• Engage with the tier process to escalate changes or tasks that are off track.
• Conduct safety and quality walkdowns, as required.

Core Competencies:

Technical:

• Understanding of unit operations and plant equipment
• Understanding of validation (process and cleaning)
• High-level understanding of regulatory requirements related 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 fully digitalised change control execution
• Familiarity with project life cycle delivery

Business:

• Excellent communication skills, both oral and written
• Project management skills
• Data collation skills
• Decision-making and problem-solving skills
• Strong interpersonal skills

Leadership:

• Strong customer service orientation
• Collaboration skills

Key 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 2 – 6 years’ experience
• Experience 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
• Strong time management and ability to deliver to timelines
• Attention to detail and strong knowledge of GDP requirements

Apply today!

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ie

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