Graduate Quality Engineer

3 months ago

Dublin, Ireland West Pharmaceutical Services Full time

Job Summary

:

Reporting to the Senior 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.

The Rotation Graduate Program is designed to provide the Quality Graduate a diverse range of experience to complement their studies. During each rotation, Graduates will be responsible for handling daily activities, leading and working in projects that will allow them to develop their skills within a cross-functional team.

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. Maintain the 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

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