Urgent: Quality Specialist
2 weeks ago
PE Global are currently recruiting for a Change Control Lead for our client site in Tipperary: 11 month initial contract Predominately based onsite but there is an element of working from home 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 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. 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. 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 Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up to date CV Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: change control quality project
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Quality Systems Specialist
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Quality Specialist
2 weeks ago
Tipperary, Ireland PE Global Full timePE Global are currently recruiting for a Quality Specialist Quality Systems for our client site in Tipperary: 11 month initial contract Role Description The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality...
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