West Pharma Quality Technician 

Ireland, Dublin 

38587750

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