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West Pharma Graduate Quality Engineer - FTC 
Ireland, Dublin 
565192669

02.08.2024

Job Summary:

Reporting toSenior Quality Specialist, this role is part of an 18-month Rotation Graduate Program within the Quality Department. Graduates will have the opportunity to undertake three 6-month rotations across different areas in Quality such as Compliance, Quality Assurance, Quality Operations, Validation, Microbiology and Supplier Quality.


Essential Duties and Responsibilities:

  • Provide quality support and oversight to Engineering and Operations activities.
  • Draft and approve quality documentation to meet West, Customer and Regulatory requirements.
  • Support and lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive actions are implemented.
  • Ensure timely and effective closure of daily quality issues, providing support to quality and shift personnel when required.
  • Review batch paperwork for release of product for shipment.
  • Manage quality-related aspects of materials used across the business and their suppliers.
  • Execute incoming inspections, non-conformance investigations, monitoring and communication activities with suppliers.
  • Maintainthe ongoing compliance of the Quality Management System, including the coordination of document change activities.
  • Track and trend quality data to support metric reporting and quality improvements across the business.
  • Support internal and external audit programs.
  • Support NPI projects and ongoing process revalidation focusing on customer specification, Process Risk Management, Validation Master Plan, and protocol reviews.
  • Assist in managing the onsite laboratory and the validation and monitoring of the microbiological / particle testing processes required to support plant operations and regulatory / customer requirements.
  • Manage quality projects in support of continuous improvement e.g., Lean Projects.
  • Coach and drive a culture of compliance and continuous improvement.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.

Basic Qualifications:

  • Must have recently graduated with a bachelor’s or master’s degree in Engineering/Quality/Science.
  • Must have excellent communication skills both oral and written.
  • Must possess computer literacy.
  • Must possess good communication/interpersonal skills.
  • Must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.

Preferred Knowledge, Skills and Abilities:

  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
  • Knowledge of Lean / 6 Sigma tools and Project Management tools is an advantage.
  • Knowledge of and / or experience in ISO 13485, 21 CFR Part 820 and EU GMP is an advantage.
  • Able to comply with the company’s safety policy at all times.
  • Able to always comply with the company’s quality policy

Travel Requirements:

  • Must be able to travel up to 5% of the time.

Physical and Mental Requirements:

  • Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
  • Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.

Delegation of Duties:

When absent from the site duties and responsibilities will be delegated to the following designates:

  • Senior Quality Specialist
  • Respective Rotation Manager