Change Control Lead

PE Global is currently recruiting for a Change Control Lead on behalf of a leading pharmaceutical company based in Tipperary.

This is an initial 11-month contract role.

Description:

• Reporting to the Maintenance manager, the Change Control Lead is responsible for achieving the deliverables involved in 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 ensures systems are audit ready for both customers and agency inspections.
• The incumbent promotes GMP awareness at the Ballydine site, providing feedback and training to BACE team on improvements that can be made to enhance GMP and compliance as appropriate.

Responsibilities:

• Ownership and management of changes as associated with large strategic large projects. Changes may be related to processes e.g. 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 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 stake holders/ operations.
• 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.
• Conduct safety and quality walkdowns, as required.

Education and Experience:

• 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.
• 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.
• Proficiency in using digital systems for full digitalisation change control execution.
• Familiar with project life cycle delivery.
• Excellent oral and written communication skills in English.
• Attention to detail and knowledge of GDP requirements.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 020448 or alternatively send an up to date CV to [email protected]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***