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: N/A 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