Manufacturing Quality Team Lead | Tipperary
The Manufacturing Quality Team Lead is a critical role within the manufacturing and production support Centre of Excellence (CoE) of the QA and Compliance department. The Manufacturing Quality Team Lead is responsible for ensuring that all systems managed and coordinated by the function are maintained and compliant. Previous experience in a manufacturing environment is essential.
Overview of Main Responsibilities (full job description available on request):
- Manage/support and lead the team in ensuring smooth manufacturing operations, in handling deviations/CAPA, change control, complaints, customer management, critical issues, recalls, etc. and that they are in full cGMP compliance to regulatory.
- Provide oversight (Review/Approval) of GMP Record/Document in ensuring compliance.
- Ensuring manufacturing documentation is kept up to date.
- Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.
- Maintain Quality Assurance documentation.
- Support investigation of quality issues with customers and suppliers.
- Review, approve and communicate root cause and corrective action to stakeholders.
- Corrective and Preventive Actions (CPAs) - Record and monitor all problems arising, with the objective of identifying the root cause and resolution.
- Oversee the assessment and maintenance of quality-related reports.
- Provide training sessions in policies, processes, and procedures as required.
- Maintain the quality management system and site in a state of inspection readiness for regulatory inspections.
- Support Trackwise management of audits and inspections – including timely system entry, monitoring and follow-up.
- Implementation of continuous improvement of GMP processes.
- Support projects within the department and cross-functional on the site and/or within the network.
What the ideal candidate looks like:
- Bachelor/Master degree in Science.
- Ability to oversee multiple projects simultaneously.
- Experience in managing diverse relationships.
- Excellent technical writing skills.
- Experience working in a busy, fast-paced regulated manufacturing environment
What you will get in return:
- Competitive Salary (depending on experience).
For a confidential discussion and more information on the role, please contact Aisling Lane.