West Pharma Quality Technician 

Ireland, Dublin 

483976512

Job Summary:

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. Reporting directly to the Senior Quality Engineer.

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.
• Other duties as assigned.

Basic Qualifications:

• 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.
• Must be able to hold a high degree of confidentiality.
• Must have knowledge of EU-GMP
• Computer literacy required.

Preferred Knowledge, Skills and Abilities:

• Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have relevant industrial experience in a high volume injection-moulding environment.
• Basic knowledge of statistical sampling of product
• Understanding of injection moulding processes.
• Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred.

Travel Requirements:

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

• Quality Engineer
• Senior Quality Engineer
• Quality Engineering Manager