QA Specialist

Job title:

QA Specialist

Company:

PE Global

Job description

PE Global is currently recruiting for a Program Manager for a leading biopharmaceutical client based in Mayo.This is an initial 12-month contract position.Purpose:The eBR Program Manager will provide technical support and leadership to a cross functional team responsible for the implementation of electronic batch record (eBR) and review by exception (RBE).The eBR Program Manager will lead the Change Management activity including cross functional requirements gathering, business process design and architecture, system validation, and consensus building towards an end to end, integrated systems environment which meets the requirements of the Quality System. They will develop and manage a detailed project plan for all aspects of the program and will apply best practice Program Management tools and methodologies to ensure the project phases are delivered on schedule and right first time.The eBR Program Manager will be strategically aware of other Digital Transformation initiatives throughout the company and be able to identify potential sources of funding or resources, for functionality that supports the eBR rollout and/or future Digital programs.The eBR Programme Manager will operate in an environment which is largely self-managed but with oversight from the Director, Digital Transformation..Responsibilities:

• Evaluate activities, timelines and resource requirements necessary for the development and deployment of eBR/RBE
• Develop and maintain detailed program tracking tools and hold cross-functional matrix team to account for delivery of milestones across the 2 year program
• Ensure compliance with all necessary Quality and IT policies and procedures. Define and document the systems validation process with input and agreement from the Global systems owners.
• Track the Financial costs of the program.
• Create a process to measure and track financial savings resulting from the project. Create a model to predict full life cost/benefit.
• Provide timely and accurate updates to Director Digital Transformation, Site Leadership Team and ME&C management regarding project planning and execution.
• No Direct Reports but will manage multiple cross functional resources including external contractors.
• Provides cross training and guidance on project management
• Contributes significantly to the site Digital Transformation Strategy
• Adheres to and supports all EHS & E standards, procedures and policies.

Education and Experience/Knowledge

• A Bachelor’s Degree or higher in a Relevant Discipline (Technical Qualification in Engineering, Science, Technology is a distinct advantage)
• A formal qualification in Project Management would be advantageous, but not essential
• Job/Technical Skills
• Extensive experience (6+ years) in manufacturing, supply chain management, engineering, and/or process/product development.
• Experience in planning and executing projects.

Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Expected salary

Location

Ireland

Job date

Sun, 22 Dec 2024 06:46:27 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.