Quality Control Technician V Division/Functional Area: Quality
The Quality Control Technician V will operate on a 1st shift basis and will hold responsibility for QCI activities pertaining to the Global Engineering project through to Pre-Approval Inspection and GMP certification.
The Quality Control Technician V will be responsible for working with the compliance professionals with regards to developing the component incoming inspection specification with the vendor and R&D and assessing the components against the incoming specification.
The Quality Control Technician V will support the Global Engineering Project and work with the Compliance Professional and Production SME with the review and approval of defect sets and maintenance of the same.
The Quality Control Technician V will be required to support the Quality Risk management program with regards to the classification and risk assessments as they relate to the various defect categories. The Quality Control Technician V will be responsible for generation and updating of applicable QC procedures, supporting the commercial production.
The Quality Control Technician V will be responsible for working with Validations and Engineering to determine the equipment required for the incoming inspection of components and the qualification of same.
The Quality Control Technician V will assist the QC Manager in the management of key quality system elements including;
• Non-Conformance and CAPA management;
• Change Control,
• Creation and review of Component Specification Sheets
• In association with the QC Manager the Quality Control Technician V will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health
Further, the Quality technician ensures that the team work together with the Vendor technician and Vendor professionals to ensure that all component vendor issues are reported and addressed in a timely manner.
In association with the QC Manager the Quality Control Technician V will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health.
SUPERVISORY RESPONSIBILITY: (IF APPLICABLE)
The Quality control inspector will not have responsibility to hire personnel
|KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:||% of Time or
|Work with the Compliance Professionals in developing component specifications
with Vendors and R&D and assessing components against the component
|Defining the Incoming Inspection Requirements of the Components
Assessing and implementing the AQL checks that are required to be performed.
Development of AQL/Reinspection/Reprocessing Procedures
|Review and Approval of defect sets and maintenance of life cycle of the same||15%|
|Work with the Compliance Professional to support the Quality risk management
program in relation to classification of Defects
|Generation and updating of applicable QC SOPs and controlled documents||15%|
|Support the Quality systems including Change controls, non-conformances and
CAPA, Self-Inspections and Regulatory Inspections
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education and Experience
• Bachelor’s Degree in Life Science or related discipline
• Minimum of 3 years’ experience working in a GMP regulated environment, preferably in the pharmaceutical or biotechnology industries
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
• Experience to include, GMP regulated environment, preferably in the pharmaceutical or biotechnology industries
• Experience with supporting regulatory inspections
• Experience with Track wise, SAP and Coral systems
• Experience with regards Visual Inspection and Component Defects
• Experience with regards to Risk Assessments
• Strong communicator with excellent verbal, written and presentation skills
For further information on this Maintenance Technician role in Galway please contact Tommy Mckeown on 086 0100903 / firstname.lastname@example.org
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