Our client a pharmaceutical company in Mayo is looking to hire a Quality Assurance Technician for their site.
The QA Technician will operate on shift basis and will hold responsibility for all component receipt, release and return activities in support of all aspects of the business needs at the site.
Further, the Quality technician ensures that the team work together with the Vendor technician and Vendor professional to ensure that all component vendor issues are reported and addressed in a timely manner.
In association with the Senior QC Manager the component technician 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.
- Ensure activities are completed as per schedule and in a GMP compliant manner.
- Maintain releasing and issuing activities as per business needs, including but not limited to Sterilisation Paperwork, Cycle counts, Incoming Inspection, Releases, Retain Checks, In-process Checks, Complaints Investigation and Ship to Stock.
- Maintain strong relationships with management and colleagues in the business units and the quality function and customers.
- Engage with the team members, team supervisors and Management in a positive and productive manner to drive the Quality Team forward, driving improvement ideas and initiatives within the group.
- Identify and report any issues to ensure they are addressed in a timely manner.
- Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.
- Release new product related components as per the changing needs of the business.
- Represent the company in Ministries of Health inspections as deemed necessary.
- Visual inspection/AQL of manufacturing products.
- Manufacturing component releases.
- Generation of Quality data for Quality meetings and management reviews.
- In-process checks in the BUs as required.
- Maintain and participate in an effective housekeeping program.
- Training of new Technicians as required.
- Participate in cross training to allow you to operate and provide support across all BUs.
- Maintain QMS records assigned to ensure accurate and timely closure.
- CORAL: DCR submission and review of assigned documentation & component drawings.
- Process non-conforming documentation including On Holds, reprocessing, re-inspections and AQLs.
- Proven track record in a quality discipline in the Pharma/Medical Device environment
- Clear understanding of working within a regulated environment
- Computer Skills including (MS Word, Excel, SAP and PaxPro)
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Be self-directed, self-motivated and ability to prioritise competing priorities
- Good communication (both verbal and written) & interpersonal skills
- Ability to work and keep focused in a fast-paced work environment
- Must be capable of working shift work, overtime flexibility is required during holidays and busy periods.
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