Kenny-Whelan (a specialist division of the CPL group) are recruiting a Change Control lead for our client a US Pharmaceutical company with sites across Ireland. This person will be based at the Pharma plant in Ballydine, Co. Tipperary, working on contract for Kenny-Whelan . 11 months contract initially. Generally rolling in nature

Hybrid role

FUNCTIONAL GROUP NAME Engineering

JOB TITLE Change Control Lead (BACE Project)

Reports To: Maintenance Manager BACE Project (Engineering).

Job Purpose:

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.

Principal Accountabilities:

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.

Core Competencies

Technical:

• 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 digitalisation change control execution.

• Familiar with project life cycle delivery.

Business:

• Excellent communication skills, both oral & written.

• Project management skills.

• Data collation skills.

• Decision making and problem-solving skills.

• Interpersonal skills.

Leadership:

• 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.
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 GDP requirements.

All applications will be treated with the strictest of confidence

CV's to Jenn Dinan [email protected] or via the link below