Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Control Vendor Technician for their Westport site.
The Vendor Technician will operate on 1st shift basis and will hold responsibility for ASL periodic monitoring and Quality Agreement transfer to the Global system. Furthermore, the Vendor technician will work with the Vendor’s to ensure that all of the required documentation and inspection commitments have been provided to ensure that they meet the site requirements for supplier qualification. They will engage in the Supplier Quality management process to ensure all Vendors meet current regulatory and site requirements before becoming an approved vendor. In association with the Senior QC Manager and Sr Quality Control Analyst the Vendor 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.
Key/Accountabilities Weight %
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility
- 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 Vendor Management 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.
- Generation of Quality data for Quality meetings and management reviews.
- Maintain and participate in an effective housekeeping program.
- Determine the Risk Score associated with the Vendors
- Based on the risk score a periodic review period will be determined, this will be known as the site risk level which will need to be identified and entered for all of the Vendors.
- Perform the Periodic review as per the predetermined periodic monitoring assessment
- Document and address all gaps identified during the periodic review
- Transfer of local Quality Agreements into the new Global Template and onto the Global System
- Support Vendor Notification process
- Maintain QMS records assigned to ensure accurate and timely closure.
- CORAL: DCR submission and QAG review and approval.
- Attend all meetings as required or arrange an appropriate deputy. For example:
- Departmental/Tier meetings /OPEX/Project Meetings
- Safe starts/safety interventions
- Senior Quality Control Analyst
- Senior QC Manager
- Business Unit Operations Teams
- QPs in Business Units
Attributes in Education, Experience/Knowledge and Physical Demands
- Proven track record in a quality discipline in the Pharma/Medical Device environment
- Clear understanding of working within a regulated environment
- Computer Skills or ability to learn (MS Word, Excel, SAP and QMS)
- Excellent Report writing skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Be self-directed, self-motivated and ability to prioritise competing priorities
- Excellent communication (both verbal and written) & interpersonal skills
- Ability to work and keep focused in a fast-paced work environment
- Able for physical activities such as lifting and carrying, locating components into label boxes, trolleys etc
Compliance and Integrity
You will be responsible for conducting your activities on behalf of the company consistent with a high standard of business ethics and in compliance with the laws and regulations that govern our activities.
For further information on this Quality Control Vendor Technician in Mayo please contact Clara Burke on 086-8168273/ email@example.com
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