Job Description

Quality Change Control Lead

An exciting opportunity exists for a Change Control Lead, to join a highly skilled Project team, based on site at a Tipperary based Pharmaceutical multinational. The successful candidate will be involved in supporting a large-scale capital project. The role will be responsible for the ownership and management of changes through the change control system.

Responsibilities.

* 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.

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.

* Understanding of Commissioning, Qualification and Validation protocols (CQV) for process, equipment qualification and clean & black utilities.

* Good Knowledge/Experience managing Change Control System and proprietary software systems

* 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.

For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)