West Pharma Graduate Quality Engineer - FTC 

Ireland, Dublin 

565192669

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