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Quality Technician

2 months ago

Dublin, Ireland West Pharmaceutical Services Full time

Quality Technician

Requisition ID: 65350

Date: Sep 12, 2024

Location:

Dublin, Leinster, IE

Department: Quality

Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Summary:

Performs a variety of tasks and conducts test procedures in regards to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. Reports directly to the Senior Quality Engineer.

Requirements:

  • Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have relevant industrial experience in a high volume injection-moulding environment.

  • Computer literacy required.

  • Must possess good communication/interpersonal skills; must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.

  • Must understand the principles of Batch Control and FIFO.

  • Basic knowledge of statistical sampling of product

  • Must be able to hold a high degree of confidentiality.

  • Must have knowledge of EU-GMP

  • Understanding of injection moulding processes.

  • Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred.

Essential Duties and Responsibilities:

  • Review and approval of metrology reports, where appropriate, for batch release and validation purposes

  • New product validation, analysis and reporting.

  • Quality support to Engineering and Production Departments.

  • Establish and maintain documentation in line with West Dublin and West Pharmaceutical Services Quality Systems.

  • Liaise with customers and suppliers on new and existing projects.

  • Receiving and inspection of incoming goods and materials

  • Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.

  • Maintain good communications both internally and externally.

  • Ensures that all metrology equipment is correctly calibrated.

  • Assists shift personnel with quality issues and/or measurement techniques.

  • Assists in problem resolution with customers.

  • Makes periodic audits as requested and completes necessary documentation.

  • Archives quality records, samples and log procedures.

  • Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.

  • Batch paperwork review and final decision to release product for shipment

  • 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.

Delegation of Duties:

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

Job Title Quality Engineer

Job Title Senior Quality Engineer

Job Title Quality Engineering Manager

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.