Qa Specialist

Overview

QA Specialist

This role will be part of our clients global supply quality team supporting oversight and maintenance of contract manufacturers.

It is an initial 12 month contract with the view to an extension.

This is a remote position.

Responsibilities

Act as disposition manager ensuring that batch disposition activities are completed in line with Amgen standards

Manage and drive Quality records to closure including deviation records, investigation reports

Initiate Quality records for supplier related changes.

Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed

Provide data to the networks to support Quality Management Processes)

Prepare, review and approve SOPs and other GMP / GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

Take part in operational and quality improvement initiatives, programs, and projects.

Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

Requirements

Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them

Previous experience in batch release activities

Good working knowledge of SAP

Experience in investigations, project management and trending and analysis a benefit.

Relevant experience in Supplier Management, raw materials, packaging components, and / or device manufacturing.

Understanding of the applicable manufacturing / testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

Proven experience in designing and / or improving processes at conceptual level

Desire to partner with internal and external stakeholders across teams

Understanding of industry requirements / expectations of a robust Quality Management System and documentation.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone

David O'Connell

at

• 353 (0) 86 1263871

or send your profile to

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