- Reference: D47305
- Job Type: Permanent
- Location: Dublin West
- Category: Engineering, Technical & Manufacturing
PLANT QUALITY MANAGER, PERMANENT, DUBLIN
The Plant Quality Manager will be accountable to ensure the Quality Management System is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance will regulatory requirements and ISO requirements as they pertain to the plant, customer specifications and corporate quality procedures. The Plant Quality Manager assures consistent quality of production by developing and enforcing best in class systems; validating processes and providing documentation to support our processes. The Plant Quality Manage will be an ambassador for high standards.
Oversee Quality Review of batch documentation and testing and determine disposition for all production batches and incoming raw materials. Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
Customer Management including facilitate/host customer audits, ensure robust and effective corrective action to customer audit observations, review/approve quality agreements with customers, partner in the resolution of quality issues and requests for information by initiating effective interdepartmental communication, manage ISO certification and maintenance of certification.
Facilitate management review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System and Supply Chain.
Execute talent management activities with direct reports, if applicable. Ensure proper performance management, training and development of direct reports. No lost time accidents or medical treatment injuries within team
- Implementation and oversight of a Quality Management system that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
- Implementation of document control and review/approval of controlled documents
- Implementation of change management and review of all change controls
- Implementation of supplier quality management and performance of supplier audits as appropriate
- Compliant management including robust root cause analysis and CAPA
- Implementation of effective Internal Audit Program, ensure adequate Training Program is in place
- Implementation of an applicable Validation Master Plan including equipment, process, product, sterilization and test methods,
- Implementation and oversight of quality control laboratory and review/approval of QC testing
- Oversight of cleanroom practices including qualification,
- Monitoring and behavior, implementation of Quality Risk Management in relevant aspects of the QMS
- Responsible for implementation of the Global QMS e-tool (EtQ) at the plant, and support the WW QS Manager in development and deployment of policies and procedures for elements of the global QMS.
Education & Experience Requirements
- Bachelor’s Degree in Engineering or Life Sciences –related field – Essential
- Master’s degree – Desirable
- Quality accreditation
- Competent IT skills
- Strong knowledge of ISO and cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
- Must have experience in performing risk analysis (e.g. FMEA, FTA, Risk Ranking/Filtering)
- Demonstrated understanding of Lean Manufacturing concepts.
- Strong project management skills.
- Must possess excellent verbal and written communication skills.
- Strong computer skills required including Microsoft Word, Excel, Visio, PPT, and Project.
- Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.
- Must be able to lead, manage, and motivate a team through direct management or matrix management.
- Proven experience of at least 6 years in a similar role in a regulated industry and Quality Function
- Proven experience in Product Development, Process Development
- Minimum 3 years in a Managerial role
Interested? Contact us now:
- For more info on the role, contact Eva Strain on 01 66 200 88 or email email@example.com
- For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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